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



Medical Devices

Tissue Products

Food & Beverages, Nutraceuticals

Download Our Regulatory Affairs White-Pager

What Our Clients are Saying

“I just want to express my appreciation for your impressive AuditUtopia™ program. During a recent PAI inspection from the FDA we were challenged with 211 requests for documents. I do not know how we would have managed without the AuditUtopia™ software. Our Quality staff was able to execute FDA requests rapidly and flawlessly, communicate in real time between the various groups, and all of this resulting in less stress overall. The inspection was a success. We received our commercial license, and AuditUtopia™ was a big part of achieving that milestone.”

“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.”

“Successful FDA inspections are dependent on having a combination of seasoned individuals responsible for hosting, note-taking, and running requests back and forth from the conference room. AuditUtopia™ has been tested during my simulated FDA mock inspections and it serves to overall stream-line the inspection process. As a former FDA investigator, I fully endorse AuditUtopia™ and recommend it to any company working in a regulated industry. It will impress any FDA investigator that comes to your facility for an inspection. Successfully managing FDA inspections is the bottom line.”

How Can We Help You?