Regulatory Affairs

Your One-Stop For All Your Regulatory Needs

PSC Biotech® experts have extensive knowledge and experience with the submission of Global Regulatory Documents. We provide all highly regulated industries with pre-market and post-market activities for global life science submissions. You can turn to our experts to ensure a timely approval of multiple global submissions. Our Regulatory Affairs Team has vast knowledge and experience with the submission of global regulatory documents. We are responsible for pre-market and post-market activities for global life science submissions. Our 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. 

Our Specialties

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, CTD Modules ​
  • Response to Agency questions, requests for Orphan drugs and fast track designations, protocol assistance​

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​

Develop Internal Regulatory Training, Regulatory Support

Industries Supported

Cosmetics

Drugs/Biologics

Medical Devices

Tissue Products

Food & Beverages, Nutraceuticals

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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.”

How Can We Help You?

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