Regulatory Assistance
PDG is your Regulatory Consultant
PDG offers a full spectrum of pharmaceutical consulting services supported by uniquely diverse expertise designed to target effective regulatory strategies to suit your individual needs.
Included among PDG's specialized services are the compilation of SOPs, design, planning, and implementation of pivotal non-clinical and clinical trial protocols, designation as regulatory points of contact for international manufacturers, global pharmacovigilance and post marketing surveillance responsibilities, preparation, and response for GCP/GLP and cGMP inspections.
PDG's consulting services include, but are not limited to:
- Patent and trademark assistance
- Regulatory reviews of scientific literature
- Scientific and technical writing
- Development of non-clinical protocols
- Development of pharmacokinetic protocols
- Development of clinical protocols
- Clinical site audits
- Compilation and/or assessment of regulatory submissions, including INDs, IDEs, ANDAs, NDAs, BLAs, DMFs, MAFs, 510(k)s, PMAs, HDEs, and amendments and supplements
- Preparation of FDA meeting packages
- Preparation of Investigators Brochures
- Quality Assurance assistance
- Contract negotiations with vendors, laboratories, and contract research organizations (clinical and non-clinical)
- Preparation and maintenance of Citizen Petition submissions
- Compilation of SOPs across functional areas
- Preparation of NIH and other grants including CRADA and SBIR
- PDUFA interactions/waivers
- Risk Evaluation and Mitigation Strategies (REMS)
- Review of promotional and marketing materials
- Preparation for GCP/GLP and cGMP inspections and follow-up activities
- Assistance with FDA audits, post-audit activities, field corrections, and recall activities
- Preparation of Pre-approval and Post-approval labeling
- Ongoing assessment of product labeling adequacy
- Development of post-marketing safety surveillance programs
- Automated management of regulatory databases
- U.S. regulatory point of contact for several domestic and international manufacturers
- Evaluation and Preparation of Quarterly and Annual Reports