Regulatory Affairs

Your One-Stop For All Your Regulatory Needs

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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. 

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PSC Biotech® Industry Expertise

Cosmetics, Cannabis
Pharmaceuticals, Personalized Medicine
Medical Devices, Biotechnology
Tissue Products, Cell and Gene Therapy
Food & Beverages, Homeopathic, Nutraceuticals
LIFE SCIENCE EXPERTISE ON DEMAND

What makes PSC Biotech® the partner of choice for leading life science companies? It’s our full-service approach to ensuring your facilities, equipment and processes meet regulations set by leading regulatory bodies. Access the full spectrum of software and service solutions your company needs to thrive. Contact a PSC expert today.


We accelerate with our trusted partners

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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​

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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​

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Regulatory Agency Standards

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

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Develop Internal Regulatory Training, Regulatory Support

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

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Risk Benefit Analysis for Regulatory Compliance​

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

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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​

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!

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