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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...
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...
Grant Writing For Regulatory Processes – Whitepaper
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...
Navigating Regulatory Inspections: Top 5 Remediation Best Practices
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...
Annual Submissions for US in regulatory processes
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.
Maintaining Project Documentation and Records in Life Science
Life science companies deal with tons of data; this data could be related to processes (manufacturing, process controls, equipment, administrative, financial, legal, medical), product (physical attributes, study reports, analytical documents, batch records),...