The importance of pharmaceutical industry experience at this critical juncture in the drug development program cannot be understated.
PDG’s experience in execution and oversight of product development includes clinical studies (Phases I-IV), toxicology programs, formulation and CMC-related assignments, Good Manufacturing Practices (GMP), statistical assignments, product labeling and project management.
PDG will work with you to establish a list of assignment deliverables. This will include parallel development timelines across company disciplines as well as reasonable corporate go/no-go benchmarks. Examples of the types of specifics that PDG routinely and successfully addresses include:
- DMF reviews and facility audits to help ensure trouble-free operation and GMP compliance that meets global standards.
- Investigational New Drug Application (IND) and/or Special Protocol Assessment (SPA) compilation and submission as applicable. The SPA is a regulatory tool that promotes FDA agreement with your development program.
- CRO/CMO selection, audit, qualification, contract negotiation, and administrative management of CROs/CMOs across study life/product lifecycle including travel to sites. We work with our clients to keep CROs/CMOs on time, on budget, on protocol and GCP/GMP compliant.
- GLP/GCP compliance that will support absorption, distribution, metabolism and excretion (ADME), pharmacokinetics (PK), bioequivalence and clinical trials, both pilot and pivotal.
- Protocol/Investigator Brochure draft, review and edit.
- Preparation, rehearsal, and if necessary facilitation of FDA pre-approval inspections.
- Plan and monitor required studies. PDG helps ensure that all of the above deliverables have moved in parallel and that release specifications for investigational supplies are met. We travel to study sites to evaluate ongoing compliance with protocols.