Gregory P. Martin
Complectors Consulting, LLC
1022 Heather Court
Pottstown, PA 19465
Phone:
(484) 942-3200
E-mail: greg.martin@complectors.com
Website: www.complectors.com
Greg is Principal Technical Consultant for Complectors Consulting, which focuses on pharmaceutical analysis (particularly dissolution), regulatory and compendial issues, and improving lab efficiency. He brings over 29 years in the pharmaceutical industry, most recently as Director in Pharmaceutical Analytical Chemistry, within the Pharmaceutical R&D division at Merck Research Laboratories. He has trained many people to perform and troubleshoot dissolution method development and led several teams which have streamlined the drug development process.
An example of his consulting scope can be demonstrated when, within Merck, Greg built an overall GMP-compliant system that successfully underwent internal and external inspections, systematically addressing personnel training, equipment and electronic systems qualification, and data documentation and review. He followed that up by working with the internal GMP Compliance group to propagate the approaches used to other departments. As Vice Chair of the USP General Chapters Expert Committee, he created significant impact on several General Chapters, including Residual Solvents, Validation, Instrument Qualification and Chromatography.
Areas of expertise for consulting or training:
- Pharmaceutical analysis
- Dissolution
- HPLC stability indicating methods
- Method validation, verification or transfer
- Troubleshooting
- Specifications
- Compendial topics
- Dissolution
- Residual solvents
- Instrument qualification
- Method validation and verification
- Chromatography
- ICH Quality guidances
- Q2 - Validation
- Q3 - Impurities and Residual Solvents
- Q6 - Specifications
- cGMPs
- Laboratory compliance
- Inspection/Pre-approval inspection readiness
- Regulatory musts vs. wants
- CMC content
- Specializing in early phase regulatory filings
- Improving business processes
- Cycle times
- Interactions within and between groups
- Streamlining to reduce resource requirements
- Personnel development
- Strengths identification
- Strategic Planning
- Training
