Clinical & Regulatory Affairs
Expert knowledge and experience matters. Pharmatech’s team of seasoned industry experts will work with you to build a regulatory strategy that will meet all your clinical and regulatory affairs needs. Our team has a deep understanding of the rigorous regulatory requirements in all the major markets and beyond. This positions us to address the ever-changing regulatory requirements for emerging technologies and innovative drug and device therapies, which pose unique challenges for industry and regulators alike.
From formal agency meetings, development of good clinical practices, pre-submission packages, clinical trial reports 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 in the design of good clinical practices to support 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