PSC Biotech® has been a trusted partner in regulatory affairs, providing expert consultants who help life science companies navigate local and global compliance requirements throughout every stage of product development. Our comprehensive services include regulatory strategy development to align product roadmaps with evolving standards, detailed risk-benefit analysis to drive strategic decisions, and meticulous labeling reviews to ensure adherence to FDA, EMA, and international guidelines. We also offer robust support in pre-clinical and process data review, clinical study documentation support across all phases of trials, seamless submission file management, and continuous approval process support, from establishing timelines and monitoring submission progress to ensuring effective communication with regulatory bodies.
REGULATORY AFFAIRS
Comprehensive Regulatory Solutions for All Your Regulatory Needs
YOUR TRUSTED PARTNER IN REGULATORY AFFAIR CONSULTANTS
Our Regulatory Affairs Services Include:
• Regulatory Strategy Development: Align your product roadmap with evolving regulatory requirements to minimize risk and streamline approvals.
• Risk-Benefit Analysis: Evaluate potential risks and benefits to inform strategic regulatory decisions and ensure compliance with safety standards.
• Labeling Review: Ensure product labeling meets FDA, EMA, and other international guidelines for accuracy and compliance.
• Pre-Clinical and Product Process Data Review: Assess data integrity, product development milestones, and manufacturing processes to align with regulatory standards.
• Clinical Study Documentation Support: Comprehensive review of clinical study documentation across all phases (Phase 0, Phase I, Phase II, Phase III, and Phase IV clinical trials).
• Submission File Management: Create, compile, and manage submission documents for streamlined regulatory filings.
• Approval Process Support: Establish timelines, monitor submission progress, and ensure effective communication with regulatory bodies.
Industry Expertise
Pharmaceuticals and Personalized Medicine
Medical Devices and Biotechnology
Tissue Products, Cell, and Gene Therapy
Cosmetics and Cannabis
Food & Beverages, Homeopathic, and Nutraceuticals
Partner with PSC Biotech® Today!
Our dedicated consultants act as a seamless extension of your team to provide the highest quality service and compliance assurance. Whether you require assistance with submissions, strategy development, or regulatory maintenance, PSC Biotech® is your trusted partner in achieving regulatory success.
Accelerate your success with PSC Biotech®
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.
CONTACT OUR EXPERTS