Regulatory Affairs Consultants Role and Requirement in the current changing times

Regulatory Affairs Consultants Role and Requirement in the current changing times

OUTLOOK

The life sciences industry is evolving rapidly and so are the challenges associated with it. The business strategy ahead is to be proactive, time-bound results and the staff trained to be able to communicate and execute all documentation requests rapidly and flawlessly. The life sciences regulatory outlook for companies in these times should be to incorporate technology-driven, an experienced team to support global agency requirements including scientific, manufacturing, compliance, and legal.

UPDATED REGULATORS REQUIREMENTS FROM THE LIFE SCIENCE INDUSTRY

Regulators now require life sciences compliance programs to operate at a higher level. Due to the current pandemic, new pricing and privacy provisions continue to become law as drugs are taking center stage in the political debates around health reform. The stakes have gone higher and regulators have made it clear that “paper compliance” is not enough and that companies are expected to maintain a comprehensive, real-time view of their compliance programs’ effectiveness. The Life sciences companies have to be more aware and ready as they are responsible for helping to improve the lives of millions of individuals and maintain a high standard of public trust.

HOW DOES A REGULATORY CONSULTANT HELP

Regulatory consultants are responsible for pre-market and post-market activities for global life science submissions. Roles further include developing and implementing regulatory strategy, provide guidance on regulations and standards, review and maintain project documentation and records, participate in risk-benefit analysis for regulatory compliance, generate and manage submission files, and review and author submission documents. Regulatory Affairs Consultants have aids in the timely approval of multiple global submissions.

With so many complex issues in play, Regulatory Consultant will play a vital role in strategic conversations on product development and also try to make sense of a constantly changing life sciences regulatory environment.

VALUE ADDITION OF A REGULATORY CONSULTANT

A regulatory consultant will add value to your company by sharing valuable insights, helping you develop strategies that you can easily incorporate in your business model  and match the requirements with current changing times. With compliance top of mind for all involved when a new product nears launch, a new system is brought online, or a new business relationship is explored, companies can be better equipped to do more than comply with life sciences regulations. Active compliance can also be a force to support the needs of your teams, and the process and technological tools we use, to be better integrated and aligned in your company’s mission.

The Importance of Excellent Requirement Specifications & Risk Assessments

The Importance of Excellent Requirement Specifications & Risk Assessments

Here’s Why You Need Seasoned Validation Experts for Your Business.

As one of the largest providers of Commissioning, Qualification and Validation services (CQV services) – PSC is a global behemoth in the life science industry. Our clients enjoy the benefit of our local and global reach. PSC offers a wide range of services, from facilities equipment to calibration matrices.

Because of the wide range of services that we provide, we can help our clients through every stage of a project.

Our experts focus on delivering practical and compliant results. That is why we have a proven success ratio on complex requirement projects for world-renowned clients.

But how can our services be of such importance to businesses?

Take User Requirements Specifications as an example.

User Requirements Specification (URS)

User Requirements Specifications describe what they REQUIRE from a software solution, new equipment, or new process. You want to write the specifications before the system is created or purchased.

The end-users or the owners of the system usually know what they want the system to do and the provide the input to write the URS.  The URS is a critical part of software, equipment, or process development. If you’re unclear on what you’re trying to deliver – you’ll have a hard time knowing if you’ve successfully delivered it.

With the help of excellent user requirements, your business can achieve:

  • A better end-to-end solution
  • Satisfied customers
  • Reduced cost
  • Shorter duration

A good URS provides a firm foundation for a successful project.

You also need to evaluate the risks for any project and PSC has the risk assessement service capability for your system, project, or equipment.

Risk Assessment Services

Risk assessment is a vital component of any project.  Risk assessment gives your business a solid analysis of the risks associated with your system, project, or equipment so you can achieve the results you want minimizing the cost while maintaining safety, reliability, and compliance. PSC understands the ins and outs of risk and risk assessment.

Our risk assessment professionals can be trusted advisors for your business while working alongside your business’s internal team.

Why Do I Need a Risk Assessment?

Think no further than Three Mile Island, Fukushima Dai-Ichi, etc.  Did they need a risk assessment?  Risk assessment is your primary tool to undertand and quantify risk, a necessity for every business in any industry. Through a risk assessment, you can understand the risks your business is exposed to. Risk assessment helps you to identify and implement cost effective measures to control or eliminate risks and adopt procedures that help minimize uncertainty and protect your bottom line.

Conclusion

Our seasoned professional are leaders of the life science industry  PSC can provide end-to-end solutions from User Requirements Specification, Risk Assesssments and the associated implementation services to our customers.

Hire PSC professionals and you’ll be able to design, commission and build systems and facilities a lot quicker with less angst. Your products will reach the market faster, and you’re going to have a better return on your investment.

To know more about our PSC’s CQV services, contact us today or click here to know more.

Professional Technical Writing Services

Professional Technical Writing Services

We Have Technical Writers Trained in Good Documentation Practices

There’s an industry event happening and you have been invited to present a whitepaper. Now, you need someone who can write the whitepaper for you. You need someone with the appropriate technological literacy.

Someone who can understand and elaborate on, for example, why your latest innovation changes lives and craft a compelling, persuasive paper that will grip your readers.

When you hire PSC – that’s the kind of balance we provide on a daily basis. Our highly educated and experienced team members have technical writing experience on various topics.

Wide Array of Experiences

From Global Harmonization to Regulatory Affairs – our writers have written on anything you can imagine. This means – whenever you hire us, our writers will ask questions from your designated subject matter experts (SMEs).

Gauging the right information enables our team to produce the excellent quality that you need. When our team has gathered all the data, we’ll be able to create all kinds of content. Our team consists of experts in:

  • Drafting
  • Editing

And reviewing technical documents such as:

  • Protocols
  • Summary Reports
  • Specifications
  • SOPs (Standard Operating Procedures)
  • Manuals

Here’s How You Can Go Wrong With Technical Writing

Many mid-sized engineering, startups, high-technology, and manufacturing companies don’t have a technical writer in their staff. So, whenever there is a need to write a technical document, who do you assign to write the document?

Do you assign the duty of documentation to the project’s engineer, marketing communications team member or a technician in the company?  Business owners sometimes forget that writing is a skill in itself. Knowing a great deal about something doesn’t ensure that you’ll write well about it, too.

Even when businesses decide to hire a technical writer, they can make another crucial mistake. Since “price” is often the only priority, managers hire the cheapest resource which often leads them to hires the wrong resource. No one ever considers hiring a technical writing professional to write it right.  Businesses often end up with a writer who isn’t experienced or has the wrong skill set. Here’s why:

  • Everyone in your company has tasks of their own.
  • You can’t expect professional work from a non-professional.
  • Getting quality work at bargain prices is hard, and sometimes impossible.

Why You Need A Professional Technical Writer

A professional technical writer is well worth the money you spend. This can especially be true if you’re hiring a technical writer for a specific task.

Here are three reasons you should always hire a professional technical writing service:

  1. A professional technical writer devotes all of their time to your project. You can’t expect the same when you designate a writing task to an internal employee since they’re going to have work of their own, too.
  2. A technical writer is an expert on evaluating the content strategy, timeline and plan. That is why they are able to deliver on time
  3. Technical writers are aware of all the tools they can use to create content for you. Because of the tools they have access to, they are able to create content that is unmatchable and unique.

To hire us for your technical writing service needs, contact us today or click here to know more.

Revolutionize Your Business with State-of-the-Art Validation Equipment

Revolutionize Your Business with State-of-the-Art Validation Equipment

The life sciences industry validates and monitors everything.  The life sciences industry continuously collects validation and monitoring data.  The life sciences industry adopts the latest technologies.   The life sciences industry automates.  The life sciences industry needs state-of-the art validation equipment.  PSC has state-of-the-art validation equipment for your needs.

Promising Rewards

To make sure your business stays at the forefront of the industry – you must have the equipment to validate, monitor, and support your operations. The market around is full of businesses that constantly diversify their portfolios, and brave startups are coming after you to steal your thunder.  If you don’t maintain compliance, someone else will step right in and take it away.

In challenging times like these, the benefits of new devices can be a differentiator for your business. More important than buying a specific solution – is using trusted solutions that enable you to work more efficiently.

The Kaye Validator ® 2000 simplifies the process of thermal validation, particularly under extreme conditions such as autoclaves and dry heat ovens or ultra-low temperature freezers.  The Kaye Validator reduces the time needed to set up a thermal validation.

Wireless temperature, temperature and humidity, and other monitors from Lives International, Ellabs, and Cryopak can provide you with almost unlimited flexibility to validate and monitor environmental conditions for any equipment or facility.

Instruments like these enable you to stay competitive in an ever-changing market. But operating a business in an industry that is so prone to an upheaval can feel daunting at times.

It always feels like you’re on the brink of change!  Because you are!

Heightened Industry Standards Means Never Ending Validation

The life sciences industry continues to improve and heighten the current Good Manufacturing Practice standards.  You need to adapt to and adopt the latest standards just to remain compliant.  This means adopting improved technologies and improved levels of performance in your validation programs.

Cleanrooms are crucial to many life science operations.  CLiMET® monitoring and validation equipment gives you the state-of-the-art tools to show and maintain environmental compliance..

CLiMET’s stainless-steel exterior, ease of use, and touch-screen LCD interface  make environmental validation and monitoring a lot easier.  Oh yes, they are also incredibly portable.

We know the future.  Higher standards.  Never ending validation and monitoring.  A constant drive to improve performance and control costs while maintaining and improving the quality and reliability of our products, processes, and facilities.  If you don’t do it, your competition will leave you behind.

Cost-Effectiveness: Renting Can Be Better Than Owning

Even though the industry is moving at a blistering pace, owning validation equipment can be too much of a financial commitment for an average consumer. If your needs change, buying a device and watching it slowly go obsolete can be a devastating experience.

We recommend you consider renting validation equipment.  Renting gives you flexibility and cost control.  You rent what you need, when you need it, for as long as you need it.

The Bottom Line

Your business stands to gain from the exciting technological advancements to meet the needs of the life sciences industry.  Selecting the right equipment for your business can be a challenging task.  Let our skilled professionals help you to choose the right equipment and adopt the best operational practices. We understand that choosing the right validation equipment can save you both time and money.

PSC can provide you with state-of-the-art equipment.  We also excel in commissioning and qualifying validation equipment anywhere in the world. If your business has validation equipment needs, contact us today or click here to learn more.

 

Benefits of Renting CLiMET® Validation Equipment

Benefits of Renting CLiMET® Validation Equipment

CLiMET® particle counters and air samplers deliver precise test results so you can validate or monitor your clean rooms and controlled environments to get or stay compliant.   CLiMET® instruments are state-of-the-art, robust, and easy to use.   You should buy CLiMET® equipment for your ongoing needs.  When you need CLiMET® equipment for a project or an increase in validation or monitoring activity, consider renting the calibrated CLiMET® equipment you need from PSC Biotech™.

Use the Best Validation Equipment, Use CLiMET®  

When your company claims that an area is a clean room or controlled environment, current Good Manufacturing Practices (cGMP) require that you prove it.  Validation is how you prove it meets the specifications for the first time.  Monitoring is how you show that you continue to meet your specifications.  CLiMET® non-viable particulate and viable microbial air samplers are the best equipment to validate and monitor that your clean room or controlled environment meets the ISO 14644, European Union Grade, or other controlled environment specifications that you claim.  CLiMET® equipment is accurate, precise, easy-to-use, and robust, is in calibration, and was calibrated by CLiMET®.

Use Calibrated CLiMET® Equipment, Avoid Failure Investigations

If your particle counter or a microbial sampler is operating Out-Of-Tolerance (OOT) during its calibration interval or is out of its calibration interval, you need to do an investigation to determine if your validation or monitoring work was valid.  Investigations cost money, take time, and take your resources away from productive activities.  PSC’s calibrated CLiMET® equipment provide you the highest assurance against calibration issues affecting your work.

Who is CLiMET®?

CLiMET® is an industry pioneer and innovator that manufactures, distributes, services, and calibrates particle counters and microbial air samplers for over 50 years of experience. CLiMET’s line of pharmaceutical and industrial grade environmental monitoring equipment are drop and vibration tested, and specifically designed for long life.  Pharmaceutical and biotechnology organizations choose CLiMET® equipment for their unparalleled accuracy, measurement stability, and extremely high quality.  CLiMET® instruments have a straightforward control interface with multiple levels of security for control over instrument test conditions.

Rent the Best from the Best

PSC Biotech™ is the proud exclusive rental company of CLiMET® air samplers. Our rental equipment portfolio includes

  • CLiMET® 750t Laser Particle Non-Viable Particle Counter
  • CLiMET® 1054 Laser Particle Non-Viable Particle Counter
  • CLiMET® 90 Viable Air Sampler

Benefits of Renting CLiMET® Instruments 

Lowered Cost of Quality Control

The cost of one failure investigation frequently exceeds the rental costs or purchase price of a particle counter or microbial sampler.  Purchase the particle counters and air samplers you need to optimize your capital investment. Rent additional particle counters and air samplers when you need them to minimize your operating costs while maintaining your quality standards.

Expert Installation and Commissioning Assistance

Renting CLiMET® air samplers from PSC Biotech™ gives you the benefit of our expert assistance.  PSC Biotech™ provides installation, commissioning and validation support for all rental equipment to worldwide facilities.

Ending Note

Renting validation equipment can enable you to reduce costs, maintain compliance, and avoid deviations and investigations. CLiMET® instruments let you use the best non-viable particulate and microbial air samplers for your validation and monitoring needs while managing cost.

PSC Biotech™ rents calibrated CLiMET® and other validation equipment and provides best-in-class support throughout the lifetime of the equipment. Let our experts assess your requirements and recommend the right CLiMET® equipment for you to rent or buy for your operations.

Contact PSC Biotech™ at https://biotech.com/.