Recent Clients and Collaborations
Recent Clients and Collaborations
Testimonials
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.
Waheed Sheikh, Ph.D. President and Founder,
SL Pharma Laboratories, Inc.
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
James Gregarani, Vice President of Pharmaceutical Development,
Novel Laboratories
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 preparation for New and Ongoing Generic Product Development Programs
- Technical Transfer, Scale-up and Production Troubleshooting Support for an Oral Solid Dosage form
- Development and Implementation of Training Programs for Pharmaceutical Development Staff
- Review, Revision and Preparation of SOPs
- Pharmaceutical Development Expertise for Patent Litigation Support
- Collaboration on the Design and Content of Pharmaceutical Related Websites
- Health Authority Interactions – US, EMA and Canada – in Support of INDs/IMPDs, NDAs/NDSs/MAAs, and sNDAs/Variation Submissions– Inclusive of Advice, Briefing Document Preparation, Face-to Face Meetings – Small Molecules and Botanical Drug Products
- Collaboration on the Enhancement of Current Business Model for Expansion into the Pharmaceutical and Biotechnologies Industries
- Supplier/Vendor Due Diligence and Audits
- Equipment Evaluation and Recommendation for Purchase
- Design and Implementation of a Quality System for an OTC Topical Product
- Provide Regulatory CMC Strategy and Documentation Preparation for a Phase 3 Topical Antiviral Product
Companies Supported
- AC Compacting Inc
- Aditum Bio
- AIM ImmunoTech Inc
- Amneal Pharmaceuticals
- Arvelle Therapeutics
- Axovant Therapeutics
- Biocidium Biopharmaceuticals
- Biogen
- BusStim
- Centrexion
- Carboninnovations.com – The Black Patch
- Cerecor Inc
- Collegium Pharmaceutical
- Dermavant
- DOAR
- eNet Web Services
- Emery University
- Esperion Therapeutics
- Gavis Pharmaceuticals
- Genentech
- Hospira
- Lycera
- LytPage
- Marinus Pharmaceuticals
- National Institute of Health
- NeuGATE Theranostics Inc.
- Neurotez
- Novel Laboratories
- Nowarta Biopharma Inc
- NuvationBio
- OneSource Regulatory
- Pfizer
- PharmOps
- Protagonist Therapeutics
- Roivant Sciences
- Shabas Solutions
- SKY Biopharma Inc
- SLPharma Labs Inc
- Somerset Therapeutics LLC
- Sorrento Therapeutics
- SPR Biosciences
- Step Change Pharma Inc
- SysTECH
- Teva
- Teris Bio, Inc
- TrialSpark
- Valeant Pharmaceutical International
- WinTac Limited
- wit – Expert Witness Agency