PDG offers a full spectrum of pharmaceutical consulting services supported by a unique diversity of expertise in designing targeted and 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 the regulatory point 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: | Regulatory reviews of scientific literature | | Scientific and technical writing | | Development of non-clinical protocols | | Development of pharmacokinetic protocols | | Development of clinical protocols | | Development pharmacovigilance assessment programs | | Compilation of regulatory submissions, including INDs, IDEs, ANDAs, NDAs, BLAs, 510(k)s, PMAs, PDPs, HDEs, and MAFs, amendments and supplements | | Preparation of Investigators Brochures | | Contract negotiations with vendors, laboratories, and contract research organizations | | Preparation and maintenance of Citizen Petition submissions | | Compile SOPs across all functional areas | | Automated management of regulatory databases | | Clinical site audits | | The preparation of NIH and other grants including CRADA, SBIR, STTR, PEPFAR | | PDUFA interactions/waivers | | Patent and Trademark assistance | | Preparation for GCP/GLP and cGMP inspections and follow-up activities | | Preparation of FDA meeting packages | | Quality Assurance assistance | | Review of promotional and marketing materials | | Assistance with field corrections and recall activities | | Risk management action plans | | U.S. regulatory point of contact for several domestic and international manufacturers |
 To find out more about these and other regulatory consulting services available from PDG, be sure to contact us.
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