Regulatory Affairs

Your One-Stop For All Your Regulatory Needs

PSC Biotech® regulatory affairs consultants are experts in local and global compliance measures for life science companies and products.

PSC Biotech® experts have extensive knowledge and experience with submitting Global Regulatory Documents. PSC Biotech® assists life science companies with pre-market and post-market activities. Our regulatory affairs teams develop and implement 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 Strategy​

  • Estimate regulatory risk
  • Review Labelling requirements​
  • Review Pre-clinical, Product Process, and manufacturing data
  • Review Clinical study documentation (Phase 0, Phase I, Phase II, Phase III, Phase IV clinical trial studies)​
  • Submission scheduling and approval metrics​

Review and Maintain Project Documentation and Records

  • Author or Review QA documentation, CMC related documentation, & Remediation projects​ ​
  • Review Licensing applications, dossier templates​
  • Prepare Pre-approval documentation, All Phases (0, I, II, III, IV) Clinical Trial Forms, post-approval documentation, BA/BE studies, and CTD Modules. ​
  • Response to Agency questions, requests for Orphan drugs and fast track designations, protocol assistance​

Develop Internal Regulatory Training, Regulatory Support

  • Regulatory compliance planning
  • Department and company-wide training
  • Generate training documents

Risk Benefit Analysis for Regulatory Compliance​

  • Perform gap analysis
  • Perform risk benefit analysis, analyze risk mitigation actions​

Generate and Manage Submission files and Review, Author submission files​

  • Manage submissions such as NDA, BLA, ANDA, DMF, BMF, EUA, 510(k), PMA, IDE, MDR, & Labelling, and Brand Naming
  • Applications for Licensing, Pre-Clinical, Clinical Trial Study, Establishment registration, Quality system regulation, Medical device Listing​

Regulatory Agency Standards

  • FDA
  • FSMA
  • MHRA
  • EMA
  • And more!

PSC Biotech® Consultants are experts in regulatory compliance. The PSC Biotech® company has more than 25 years of experience assisting life science companies in meeting regulatory guidelines. See our project pages for examples. PSC Biotech® facilitates regulatory submissions through strategy, analysis, and training. Benefit from the extensive PSC Biotech® expertise in regulatory strategy by contacting us today for all your regulatory needs!

PSC Biotech® Industry Expertise

Cosmetics, Cannabis

Pharmaceuticals, Personalized Medicine

Medical Devices, Biotechnology

Tissue Products, Cell and Gene Therapy

Food & Beverages, Homeopathic, Nutraceuticals

Download Our Regulatory Affairs One-Pager

What Our Clients are Saying

“During the past year, our company has been working with PSC on various activities within the development and implementation of a new medical device product. PSC offers high quality services, and we can say that we have always been satisfied by their work.”

“The skillsets that PSC provides in regulatory support helped us overcome a large obstacle in particular. The regulatory support that we had from PSC was very independent and if we had an issue, PSC consultants were willing to work cross-functionally to meet our needs. No micromanaging required. Great communication. Minimal supervision. I don’t think we would have been as successful without them. The expertise and the connections we’ve created with PSC are beyond our expectations. I’ve never had that relationship with a company like I’ve had with PSC. Just phenomenal! It made my life easier.”

“This is to certify that PSC Biotech® (PSC) has done a good job for our company in the range of auditing and consultancy. Their work was remarkably distinguished as auditors. As consultants, their work was successfully handled and enabled based on the level of expertise of their team in the U.S. and abroad.”

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