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, we have the insight to help accelerate your program using proven strategies and techniques. The regulatory approval process requires a rigorous scientific and statistical foundation upon which carefully structured documents are used to make the case for your product’s rapid and successful approval.
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). We have significant experience with combination products with special emphasis on Pre-Filled Syringes and Auto-Injector device elements. Pharmatech offers best-in-class regulatory expertise to help ensure that your submissions and agency negotiations proceed as smoothly and effectively as possible. We have experience with all types of submissions in each therapeutic area. 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