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
Avadel Pharmaceuticals LLC
Arvelle Therapeutics
Axovant Therapeutics
Biocidium Biopharmaceuticals
Biogen
BusStim
Centrexion Therapeutics Corp.
Carboninnovations.com – The Black Patch
Cerecor Inc
Collegium Pharmaceutical
Dermavant
DOAR
Dr. Reddy’s Laboratories
eNet Webservices
Emery University
Esperion Therapeutics
Gavis Pharmaceuticals
Genentech
Hawaiian Da Vine Tea Company
Hillhurst Biopharmaceuticals Inc.
Hospira
IHP Therapeutics
Integrated Pharmaceutical Systems
Lupin
Lycera
LytPage
Marinus Pharmaceuticals - Massachusetts Eye & Ear Infirmary Inc
MRSS
Natco Pharma
National Institute of Health
NeuGATE Theranostics Inc.
Neurotez
Novel Laboratories
Nowarta Biopharma Inc
NuvationBio
OneSource Regulatory
Pfizer
PharmOps
Protagonist Therapeutics
Roivant Sciences
Scimetex LLC
Shabas Solutions LLC
Sionna Therapeutics Inc
SKY Biopharma Inc
SL Pharma Labs Inc
Somerset Therapeutics LLC
Sorrento Therapeutics
SPR Biosciences
Step Change Pharma Inc
SysTECH
Takeda
Teva
Teris Bio Inc
TrialSpark
Valeant Pharmaceutical International
WinTac Limited
wit – Expert Witness Agency