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The Secret to Writing Successful Grant Proposals

The Secret to Writing Successful Grant Proposals

Grant writing aims to prepare and submit a proposal to request funding from a grant-making organization, such as a government agency, private foundation, or corporation. Grant writing involves researching potential funders, understanding their priorities and requirements, developing a proposal that meets those requirements, and submitting it for consideration.

Grant writing aims to convince the grant-making organization that the proposed project or program is worth funding and will positively impact the community or field of study. Effective grant writing requires strong writing skills, attention to detail, and the ability to communicate complex ideas clearly and concisely.

Successful Grant writing PSC Biotech
You write a grant application to secure funding for your projects. 

First, you need to determine to which Request for Applications (RFA), Request for Proposals (RFP), grant solicitation, etc., you will write the application.  This decision also determines the agency, foundation, etc., providing the grant funding.   

Make sure that you or the entity that will apply for the grant meets the criteria for the type of entities that can apply for a particular grant, for example, an NIH R-01 grant, an SBIR, an STTR, etc.     

Once you write the grant, get the RFA, RFP, grant solicitation, etc.  Read it carefully.  Outline your response.  Analyze your response outline and make sure that your grant application meets all of the requirements in the RFA, RFP, etc.    

Start early.  Give yourself and your team enough time to get the needed information, write the sections, and review them. 

Once you can meet the requirements, get the application forms, if any.  

If the granting agency allows for questions and you have questions, ask the granting agency.  Be specific.  Get specific answers.   

You need to use the specified forms and follow the directions of the grant-giving entity.  Your application may be summarily rejected if you don’t use the right forms or follow the rules. 

A grant application has 4 major parts: the work proposal, the people, the budget, and the certifications.  Let’s look at each of these. 

The work proposal tells the granting agency what you propose to do, why you propose to do it, and when you will do it.  The more data you can provide that shows a probability of success, the more likely you are to be approved and funded.  Remember to describe your work plan, the scientific rationale, the timeline, etc., for a scientifically qualified reviewer who may not be familiar with the specifics of your work.  Stay within the page limits.   

The people section tells the granting agency who will work on the proposal, how much time they will spend, their qualifications, etc.  Provide curriculum vitae and other project personnel data in the format that the granting agency asks for.  You will have to identify a Principal Investigator.  Use their forms, if provided.  Stay within page limits. 

The budget section tells the granting agency what you propose to spend for salaries, benefits, supplies, overhead, etc. This is where your Chief Financial Officer (CFO) and your accounting staff join the process. First, identify the Direct Costs,s, e.g., your salary, materials, etc., and the Indirect Costs, e.g., the administrative costs, etc., of your project. Some granting agencies will fund direct and indirect costs. Some agencies, like the US government, will fund direct costs but require a financial audit of your organization to establish an indirect cost percentage rate they would pay. For example, some companies apply for $0 indirect costs to avoid a government audit of the company.  

The certifications are the assurances you will provide that you meet all the requirements and have the necessary programs to comply with United States, State, and local laws and the granting agency’s policies. 

A grant proposal will typically include the following components: 

  • Executive Summary: A concise overview of the proposed project.
  • Background and Significance
  • Objectives: The goals and objectives of the proposed project and deliverables. 
  • Methods: How will you do it?
  • Timetable
  • Budget
  • References 
You may be allowed to add supporting materials, such as data, figures, and graphs, that help to illustrate the proposed project.

Remember, stay within the page limits. Use the proper font size, etc.
Once you have all of these sections written, do your final reviews. Then, submit your application as directed.

Ready to Take Your Grant Writing Skills to the Next Level?

If you’re ready to take your grant writing skills to the next level, start implementing these tips into practice today! Whether new to grant writing or looking to improve your success rate, remember that practice makes perfect. So don’t be afraid to keep trying, keep learning, and keep writing those grant proposals!

And if you need help, guidance, or support, don’t hesitate to contact PSC Biotech, professional grant writers.

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Benefit- Risk Assessment for Regulatory process 

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Annual Submissions for US in regulatory processes 

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Annual submissions to regulatory agencies in the US are required to maintain a product’s quality, safety, and efficacy throughout its lifecycle. These include the Annual Product Quality Reviews, Annual Safety Report, and others, each with different requirements based on the impact of changes made.

Benefit- Risk Assessment for Regulatory process 

Benefit- Risk Assessment for Regulatory process 

Benefit-risk assessment is critical to the regulatory review process for life science companies and healthcare products, including drugs, biologics, and medical devices, before it is approved for use by regulatory agencies such as the Food and Drug Administration (FDA) in the United States or other regulatory agencies in other countries. It involves evaluating the potential benefits of a product against its potential risks to determine whether it can be approved for use in patients.

Benefit-risk assessment PSC Biotech

The primary objective of the benefit-risk assessment is to ensure that the product’s benefits outweigh its risks. The assessment considers the benefits’ magnitude, duration, and risks associated with the product. Factors such as the severity and nature of the illness or condition the product is intended to treat, the availability of alternative treatments, and the population of patients who would be prescribed the product are also taken into account.

A well-executed benefit-risk assessment helps regulatory decision-making authorities make informed decisions about approving a product for marketing and use. A product with a high benefit-to-risk ratio will likely be approved for use. However, if the product’s risks outweigh its benefits or are unknown, then regulatory decision-making authorities may require additional data or impose restrictions on its use.

Ultimately, a benefit-risk assessment aims to ensure that products approved for use are safe and effective and provide a clear patient benefit. By carefully evaluating healthcare products’ potential benefits and risks, regulatory authorities can help protect public health and ensure that patients can access safe and effective treatments.

This assessment involves gathering and analyzing data from various sources, including clinical trials, preclinical studies, and post-market surveillance, to determine the overall safety and effectiveness of the product. The goal is to ensure that the product’s benefits of the product outweigh the risks for the intended population. This process is an essential to regulatory compliance for pharmaceutical companies, as it helps ensure that only safe and effective products are available to patients.  

Benefit-risk assessment is a complex process that involves many different steps, including: 

  • Identifying the potential benefits and risks of a product: This step includes evaluating the results of clinical trials and other studies and considering the intended use of the product and the population it will be used in. Although every product has side effects, the pharmacological effects must outweigh the risks. Each side effect, adverse reaction, and significant event during pre-clinical and clinical trials must be investigated and provided in detail in the specific test reports and documentation.

     

  • Gathering and analyzing data: This includes collecting data from various sources, such as clinical trials, preclinical studies, and post-market surveillance, and analyzing it to determine the overall safety and effectiveness of the product. Documenting any significant event during these stages is crucial for a complete profile of the product’s potency, strength, and safety for effective FDA assessment.

     

  • Communicating the results: The results of the benefit-risk assessment must be communicated to regulatory agencies such as the FDA, as well as other stakeholders, including healthcare professionals and patients. Several interactions occur between the sponsors and regulatory agencies during the pre-application and application stages. Typically, a product manager is assigned during the application process that becomes the main point of contact between the FDA and the sponsor. It’s important to communicate any questions or information about the product to the FDA; this would help ensure a thorough review and approval.

     

  • Monitoring post-approval: Even after a product is approved, the benefit-risk assessment process continues monitoring for any new safety concerns or efficacy issues that may arise once the product is on the market. Companies must adopt good pharmacovigilance practices to monitor the product’s safety while in the market, record any adverse or fatal events and inform the FDA immediately of customer complaints and investigate the causes and take corrective or preventive actions. 

It is s important to note that the benefit-risk assessment process is dynamic, meaning that the assessment may change as new information becomes available. Companies must adopt an efficient quality management system (QMS) and good documentation to keep track of all changes and process controls and maintain all product and process-related documentation. Such systems can help companies adapt better to product or process changes based on the benefit-risk assessments. 

Additionally, pharmaceutical companies must comply with Good Clinical Practice (GCP) guidelines set by international regulatory authorities to ensure that the data collected in the clinical trials are high quality and reliable. 

Not having a benefit-risk assessment for regulatory compliance can be a significant disadvantage for life science companies, as it can lead to: 

  • Non-compliance with regulations: A lack of benefit-risk assessment can result in a product or process not meeting regulatory standards, leading to non-compliance and penalties. Regulated products must always be compliant with each market’s specific regulations and standards. Lack of compliance could lead to FDA issuing Warning Letters, 483s, or even suspension or withdrawal of the product from the market. These regulations are in place to ensure that the product meets the highest standards of quality, safety, and efficacy.

  • Delayed product approvals: The regulatory approval process may be delayed without a thorough benefit-risk assessment. This can impact the company’s ability to bring new products to market in a timely manner without timely approval. Lack of benefit-risk assessment can also result in the rejection of an application and, ultimately, loss of time, resources, and efforts in studies for product approval.  It’s essential to communicate well with regulatory agencies for sponsors to understand the requirements for product approval.

  • Difficulty in justifying product claims: Without a benefit-risk assessment, it can be difficult for the company to justify the safety and efficacy of its products to regulatory bodies and the public. FDA requires thorough documentation of all the studies and reports that show that the product is safe for human use before it can be approved.

     

  • Difficulty in identifying potential safety issues: A lack of benefit-risk assessment can make it difficult to identify potential safety issues associated with a product or process, which can lead to negative consequences for patients and the company. This could lead to withdrawing or suspending an existing product or rejecting the marketing a new product.

     

  • Negative impact on reputation: Not having a thorough benefit-risk assessment may damage the company’s reputation and its ability to gain the trust of customers and regulators. This especially applies to products existing in the market and those not monitored for adverse events during post-approval and marketing phases. It’s crucial for companies to monitor and maintain a product as long as it is in the market, and that includes keeping track of all significant and adverse events as well as investigating product complaints and monitoring the quality over the lifecycle of the product. 

In conclusion, benefit-risk assessment is an important aspect of regulatory compliance for pharmaceutical companies as it helps to ensure that only safe and effective products are made available to patients. 

PSC Biotech has the regulatory expertise to help your company assess all benefits and risks related to any product, such as pharmaceuticals, medical devices, biological products, and animal products. PSC Biotech also provides expertise in any kind of regulatory process and compliance activities, such as authoring CTD Modules and maintaining project documentation. PSC can help you develop an effective strategy to generate and maintain post-approval products and help you understand key regulations and guidelines to help your product stay compliant as long as it is marketed.

With the help of PSC Software such as ACE and ACE Essentials, you can establish an effective QMS and keep track of all your regulatory and quality-related documentation and records. PSC professionals can help you navigate the regulatory process until the end and gain marketing approval for your product.

Ready to learn more about working with us?

Contact PSC Biotech to ensure your company complies with all regulatory standards! 

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Grant writing is preparing and submitting proposals to secure funding from grant-making organizations such as government agencies, foundations, and corporations. Grant funding can be a critical source of revenue for non-profit organizations, academic institutions, and businesses seeking to develop new projects or expand existing programs.

Effective grant writing requires a clear understanding of the grant-making organization’s priorities and objectives, strong writing skills, and attention to detail. A successful grant proposal should communicate the organization’s mission and goals, outline the proposed project or program, and demonstrate the potential impact of the funding.

Grant writing can be highly competitive, with many organizations vying for a limited pool of funds. However, with careful planning, thorough research, and expert guidance, organizations can increase their chances of securing the funding they need to achieve their goals.

 

Fill out the form below to download our white paper on Grant Writing and learn more!

PSC Biotech can provide expert guidance and support for organizations seeking grant funding.

Our experienced team of grant writers has a proven track record of success in crafting winning proposals for various industries and sectors.

We offer a range of grant writing services tailored to each client’s specific needs, including research and analysis, proposal development, and project management. Our team can help organizations identify funding opportunities that align with their mission and objectives and develop compelling proposals that demonstrate the potential impact of the funding.

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Download the “Grant Writing” whitepaper today!

Adaptive Compliance Engine® (ACE®)

Trusted Highly-Configurable Enterprise Quality Management System

ACE® allows companies like yours to adapt and grow to meet your evolving quality management needs, without coding. ACE® is a highly configurable, workflow-based software that can adapt to any business process, allowing for real-time tracking, management, and reporting of all compliance, quality, and operational activities. With all future updates being included at no additional charge, you will be able to utilize new functions immediately. With ACE®, you will minimize the administrative hassles and maximize ROI with productivity gains from day one – all while staying 21 CFR Part 11 compliant.

Logo for ACE Essentials by PSC Software
ACE Essentials® is our EQMS software that is created for all highly regulated industries. This EQMS comes equipped with all the necessary Standard Operating Procedures (SOPs) so you have a fully compliant quality management system from day one at an unbeatable price. ACE Essentials® includes document, complaint, investigation, deviation, change control, CAPA, and learning management. More processes include design control; out of specification, internal and external audit; and much more.
AuditUtopia® captures, tracks, communicates, and sorts audit activities as a real-time Inspection Audit Management System used to host inspections and audits that is trusted by life science companies worldwide. With AuditUtopia®, you can streamline your inspection process, improve response time for requests and lead end of the day meetings. Many organizations choose AuditUtopia® as the center of their inspection team to seamlessly streamline group efforts to improve response time for inspection requests.

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Regulatory compliance is essential in all industries, but it is easier said than done. Regulatory agencies strictly monitor organizations to ensure they adhere to the applicable rules and regulations. In doing so, they conduct regular inspections, and companies can have difficulty dealing with the resulting remediation processes.

Person submitting an Annual Submission in the US, PSC biotech

Regulatory inspection remediation is essential as it prevents fines and penalties and ensures a safe and healthy work environment. The remediation process involves a high degree of coordination, communication, and documentation within the organization. Companies that fail to comply with the statutes and regulations are exposed to catastrophic risks, reputation damage, and, most likely, legal action. In other words, regulatory inspection remediation is a critical aspect of business operations that must be handled with the utmost care and attention.

What is regulatory inspection remediation? 

Regulatory inspection remediations refer to actions taken by a life science company to address any deficiencies or non-compliance issues identified during a regulatory inspection. Common deficiencies and non-compliances found in inspections are related to products, processes, facilities, types of equipment, document management systems,  training, or personnel and can have a direct or indirect impact on the quality of the final product.  

Regulatory inspections are a critical component of the life science industry, as they help ensure that products and processes are safe and effective for patients. However, a regulatory inspection can also be a source of stress and uncertainty for life science companies. If deficiencies or non-compliance issues are identified during an inspection, the company may be required to take remedial action to address the issues identified as early as possible. Such corrective and remedial actions can be time-consuming and might require modifications on a larger scale as well. If remedial actions are not taken within a given amount. 

The process of regulatory inspection remediation can be a daunting task for life science companies, but it is a necessary step to maintain compliance with regulations and to ensure that products, product quality, and processes are safe and effective for patients. 

Some common regulatory inspection remediations for life science companies may include:

Developing and implementing corrective action plans:

This may include identifying the root cause of the issue, implementing measures to prevent a recurrence, and monitoring progress to ensure that the corrective actions are effective. Companies must develop procedures for performing corrective or preventive actions (CAPA) and a standard protocol for investigating root causes, deviations, non-conformances, and complaints. Such procedures must comply with Good Manufacturing Practices (cGMP) regulations to ensure that a product remains safe and of high quality.

Updating standard operating procedures (SOPs) and other documentation:

This may include revising or creating SOPs to ensure compliance with regulations and updating other documentation such as training materials and product specifications. It is crucial for companies to periodically revise all their protocols and SOPs to ensure any changes made to the processes are reflected in the protocols. Companies must keep track of regulations and any updates to the quality standards. A periodic review of all policies, SOPs, and protocols must be conducted to ensure continual compliance with changing standards and regulations. 

Conducting additional training:

It is crucial for companies to provide sufficient training and related resources to employees on all quality processes, and the importance of maintaining quality standards. This may include providing additional training for employees on existing or updated regulations and quality compliance, as well as on any new or revised SOPs and procedures. Companies can develop Learning Management Systems (LMS) that can provide training on all procedures and track training progress and metrics.  

Conducting internal audits and inspections:

As part of the periodic review process, companies must also conduct regular internal audits and mock inspections, perform gap assessments and risk assessments of their facilities, manufacturing plants, lab facilities, quality management systems, quality manuals, and all other documentation systems to ensure that companies always stay compliant with quality standards and regulations as well identify any potential issues and perform remedial actions before they can become a major problem. It is also essential for companies to conduct such audits and inspections through external subject matter experts to get an unbiased review of their systems and processes.  

Implementing quality management system:

Quality management systems (QMS) are essential to control the quality of products. A good quality management system helps companies achieve high-quality product realization, and ensure effective monitoring of the quality system and processes, thus ensuring continued suitability and capability of the processes as well as facilitating continual process improvements, reducing variations, and promoting quality system enhancements. Guidelines such as ICH Q10 can be considered by companies to establish an efficient quality system in place. Additionally, such systems also need to be compliant with relevant quality standards such as ISO and 21 CFR regulations.  


It is important to note that regulatory inspection remediation is an ongoing process and not a one-time event. Life science companies should be proactive in identifying potential issues and taking steps to address them before they become a problem. By implementing a robust QMS, conducting regular internal audits and inspections, and providing training and education to employees, companies can ensure they are in compliance with regulations and are able to effectively navigate the regulatory inspection remediation process.


Looking for support with remediation? Our team is available to provide assistance.


PSC Biotech has been providing support to life science companies in all aspects of regulatory and quality compliance. PSC Biotech has experienced consultants well versed in all quality standards and regulations to help your company reach its quality goals.

PSC provides services such as developing, modifying, or reviewing quality processes such as change control, deviations, non-conformances, CAPA, technical writing services for developing, and modifying SOPs and protocols as well as gap assessments and risk assessments. PSC also has expertise in providing training materials and developing training procedures as part of quality compliance.

PSC has subject matter experts (SMEs) that can help conduct mock audits and inspections to help identify potential issues and provide support for remedial actions. PSC also has the expertise to develop efficient QMS for your company to stay compliant with all quality regulations and standards.

PSC provides services in regulatory affairs and compliance such as generating regulatory submissions or providing guidance to understand relevant regulations. Our in-house EDMS systems such as ACE, and ACE Essentials can help your company to establish a good quality system and monitor all quality processes.

Ready to learn more about working with us?

Contact PSC Biotech to address all your quality and regulatory compliance concerns.

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Annual Submissions for US in regulatory processes 

Annual Submissions for US in regulatory processes 

Annual submissions are critical in regulatory
submission processes to maintain a product’s quality, safety, and efficacy over its duration in the market. These submissions are part of post-marketing activities for the product and are an essential part of the product’s lifecycle. While the product is marketed to end users, the product must remain consistent even after getting approval from regulatory agencies. 

Person submitting an Annual Submission in the US, PSC biotech


This also applies to manufacturing and other processes such as Quality Control (QC), labeling, packaging, and similar processes that can impact product quality and safety. Therefore, regulatory agencies require sponsors to provide documentation periodically that indicates if there are any changes to the processes impacting the product or to the product itself.  

Changes to the processes or products are classified as critical or major, moderate, and minor, based on the impact of the changes on the product quality, safety and efficacy, and end-user health.

    1. Critical or Major changes: A major change is a change that has a substantial potential to have an adverse effect on the identity, strength, quality, purity, or potency of a drug product, as these factors may relate to the safety or effectiveness of the drug product. A major change requires the submission of a supplement and approval by the FDA before the distribution of the drug product is made using the difference. This type of supplement is called and should be clearly labeled a Prior Approval Supplement.

2. Moderate changes: A moderate change is a change that has a moderate potential to have an adverse effect on the identity, strength, quality, purity, or potency of the drug product, as these factors may relate to the safety or effectiveness of the drug product. One type of moderate change requires the submission of a supplement to the FDA at least 30 days before the distribution of the drug product made using the change. This type of supplement is called, and should be clearly labeled, a Supplement – effective changes being in 30 Days. The drug product made using a moderate change cannot be distributed if FDA informs the applicant within 30 days of receipt of the supplement that a prior approval supplement is required. FDA may identify specific moderate changes for which distribution can occur when FDA receives the supplement. Therefore, this type of supplement is called and should be clearly labeled a supplement – effective changes. More details regarding this type of change can be found here.

3. Minor changes: A minor change is a change that has minimal potential to have an adverse effect on the identity, strength, quality, purity, or potency of the drug product, as these factors may relate to the safety or effectiveness of the drug product. The applicant must describe minor changes in its subsequent annual report filing.  


There are several annual submissions that pharmaceutical companies may be required to make to regulatory agencies. These changes are considered changes to the original NDA. These include:

4. Annual Product Quality Review (APQR) This report provides an overview of the quality of a product over the past year, including any issues, change controls, market complaints, or deviations that occurred. An annual product review is an effective product quality improvement tool conducted annually to assess the quality standard of each drug product, verify the consistency of the existing manufacturing process, and check the appropriateness of current specifications. This evaluation report can also highlight trends to determine the need to change drug product specifications, manufacturing processes, or control procedures. Companies must have an SOP for this process.

5. Annual Safety Report (ASR)/ Periodic Safety Update Report (PSUR):  This report must be provided by IND application sponsors. Additionally, IND application sponsors are required to notify FDA in a written safety report of: 

  • Any adverse experience associated with the use of the drug that is both serious and unexpected or 
  • Any findings from laboratory animal tests suggest a significant risk for human subjects, including reports of mutagenicity, teratogenicity, and carcinogenicity.  

The submission must be identified as: 

  • “IND submission of the safety report” for 15-day reports, or 
  • “7-day IND safety report” for unexpected fatal or life-threatening suspected adverse reaction reports, or 
  • “Follow-up IND safety report” for follow-up information.

More information on Annual Safety reports can be found here.  

    Similar to the annual Safety report for the US, the Periodic Safety Report (PSUR) is required to submit to the EMA (Europe). This report provides an overview of a company’s financial performance, including revenue, expenses, and profits. The objective of the PSUR is to present a comprehensive and critical analysis of the product’s risk-benefit balance, considering new or emerging safety information in the context of cumulative data on risk and benefits. This evaluation should ascertain whether further investigations need to be carried out and whether changes should be made to the product information or marketing authorization. 

    1. Annual Report (AR):  The Annual Report is a brief report that needs to be submitted to the USFDA within 60 days that an IND/ NDA/ANDA application going into effect. This report provides a summary of significant sections of the main application over the past year of the product being studied or marketed, such as: 

    • Information obtained during previous years’ clinical and non-clinical investigations, any adverse events, a summary of all IND safety reports. 
    • Any significant manufacturing or microbiological changes (CMC), deviations, complaints, and investigations made during the past year. 
    • A description of the general investigational plan for clinical studies for the next year. 
    • Any significant foreign marketing developments such as marketing approval in another country, withdrawal or suspensions from any market. 
    • Any change in labeling that can impact the end user.

    2. Annual Regulatory Compliance Report: This report summarizes the company’s compliance with the regulatory requirement of the country they operate in. Regulatory compliance reporting is essential to document your compliance with regulations and protect your business from serious issues.  

      3. Annual Report on Post-Marketing Surveillance: This report provides an overview of the company’s post-marketing surveillance activities, including reported adverse events and changes to the product’s labeling or packaging. This report also indicates any market withdrawals or suspension of products from any market, complaints, and corresponding investigations into the product. 

      Annual submissions are significant and a way to ensure that the product remains compliant with the standards set by the agencies and maintain the product quality, strength, potency, and safety throughout the product’s lifecycle.  

        When it comes to authoring or maintaining any regulatory submission, generation of post-marketing approval documents and annual submission documents, and supporting product maintenance throughout the lifecycle, PSC Biotech provides expertise in all such regulatory authoring or compliance activities. PSC can help you develop an effective strategy to generate and maintain post-approval products and help you understand critical regulations and guidelines to help your product stay compliant as long as it is marketed. PSC also has the expertise that can help you navigate the regulatory process right to the end and gain marketing approval for your product.  

         

        𝌕 Contact PSC Biotech to help ensure your company stays compliant with all regulatory standards! 

        PSC biotech regulatory compliance and annual submission in the US

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        PSC Biotech Services provide fast, budget-friendly, high-level expertise.

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