Clinical & Regulatory Affairs
Expert knowledge and experience matters. Ever-changing regulatory requirements for emerging technologies and innovative drug and device therapies pose unique challenges for industry and regulators alike. Pharmatech’s team of seasoned industry experts have a deep understanding of the rigorous regulatory requirements in all the major markets and beyond. From formal agency meetings and pre-submission packages through full electronic filing of your product application, our proven methodologies can help accelerate your program timelines. Today’s submission documentation is based upon rigorous foundation of technical, scientific and compliance understanding to satisfy the requirements of global regulatory authorities.
Our clinical and regulatory team has extensive experience supporting the successful development, evaluation, and commercialization of medical devices, pharmaceuticals, biologics, combination and borderline products and ATMPs (gene, cell and/or tissue-based products). Our specific expertise with combination products with special emphasis on Pre-Filled Syringes and Auto-Injector device product presentations have resulted in multiple regulatory approvals. Pharmatech’s ecosystem translates to a unique custom regulatory submission development process which can harmonize and accelerate your submissions and ensure your agency negotiations are maximally efficient and effective. We use a team-based approach to ensure you have access to the subject-matter expertise you require. If your program is seeking Fast Track, Orphan or Breakthrough Drug designation we have the experience to position your program for success.
REGULATORY STRATEGY / PRE-SUBMISSION AGENCY COMMUNICATION
CLINICAL EVALUATIONS AND REPORTS
REGULATORY APPLICATIONS AND SUBMISSIONS
ADDITIONAL CLINICAL & REGULATORY SERVICES