SERVICES
PharmaDev Partners, LLC (PDP) provides oversight and technical expertise in the areas of development (chemical, pharmaceutical, and analytical), compliance, validation, project management, regulatory affairs, and additional expertise provided by the Member Managers.
- Complete Project Management services
Dedicated Project Managers Timelines/Budgets/Resources (MS Project format) Project Scope understood by all parties
- Complete Technical Development services
Pharmaceutical Development Excipient Compatablity Pre-formulation/Formulation Development Scale Up/Process Development Clinical Trial Material and Stability Batch Preparation Preparation of Reports and Dossier Components Process Transfers to Manufacturing Analytical R&D Methods Development (Cleaning/API/Formulations) Methods Validations (Including protocol preparation) Determine appropriate specifications and test procedures Support for Pharmaceutical and Chemical R&D issues Reference Standard and Impurities Characterization Preparation of analytical reports and dossier components Analysis of Clinical Trial Materials and Stability Batches Methods Transfers to QC Chemical R&D Synthesis design Evaluation of alternate synthetic routes Specialty reactions Clinical Trial Material and Stability Batch synthesis Process design/scale up Impurities and degradation product synthesis Preparation of technical reports and dossier components Process transfers to Manufacturing
- Regulatory Affairs services
CMC regulatory strategy consultation and planning Negotiation regarding dossier contents and pre-Submission meetings with FDA CMC dossier modules writing/critique/assembly Dossier defense to regulatory bodies
- Validations
Process Cleaning Method Equipment (Manufacturing) Laboratory Computer Systems (including MRP)
- QA/Compliance and documentation
- Quality Systems design and implementation
Guidelines SOPs Training
- Packaging
Various Stages of Clinical Trials
Main Page | Services | Member Managers
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PharmaDev Partners, LLC |
| Farmville, NC USA |
| Phone: 1.252.753.3892 |
| Fax: 1.252.753.8700 |
| E-mail: contact@pharmadevpartners.com |
| Copyright 2003, 2004 PharmaDev Partners, LLC |
| Web Design: Opening The Door |
| Site Last Updated: 4.27.2004 |