Recent Clients and Collaborations

I have known Dr. Timko for over 30 years. He has extensive knowledge and experience in dosage form development and regulatory requirements to ensure expedient approval by the FDA and by other international regulatory agencies. I have consulted with him on numerous occasions on both pharmaceutical and regulatory topics, and I value his insight.
Waheed Sheikh, Ph.D. President and Founder,
SL Pharma Laboratories, Inc., June 2016
Dr. Timko has provided pharmaceutical development expertise which has helped us obtain approval of 11 ANDAs in the past 12 months. He has also designed and implemented a training program for our staff to better understand the Quality by Design concepts needed to develop commercially viable drug products within the current regulatory environment. His breath and depth of knowledge of the drug development paradigm has been instrumental in our recent successes.
James Gregarani, Vice President of Pharmaceutical Development,
Novel Laboratories, December 2015

Projects Included

  • Pharmaceutical Development Support for New and Ongoing Generic Product Development Programs
  • Regulatory CMC Support for Small Molecule Early Phase Development Programs
  • Regulatory CMC Documentation Support for New and Ongoing Generic Product Development Programs
  • Technical Transfer, Scale-up and Production Troubleshooting Support
  • Development and Implemenation of Training Programs for Pharmaceutical Development Staff
  • Review, Revision and Preparaion of SOPs
  • Pharmaceutical Development Expertise for Patent Litigation Support
  • Collaboration on the Design and Content of Pharmaceutical Related Websites
  • Health Authority Interactions Advice
  • Collaboration on the Enhancement of Current Business Model for Expansion into the Pharmaceutical and Biotechnologies Industries
  • Supplier/Vendor Due Diligence
  • Equipment Evaluation and Recommendation for Purchase