PharmaChem Associate, LLC

National Institute of Clinical Research (NICR) is proud to announce our professional affiliation with PharmaChem Associate, LLC in providing consulting services to the pharmaceutical industry. Contact us for further details.


Each principal of PharmaChem Associate, LLC,Elizabeth (Liz) T. Syage, Ph.D. and Michael (Mike) E. Garst, Ph.D., MBA, has over 30 years pharmaceutical development experience.

PharmaChem Associate, LLC offer chemistry and API development expert advice and services to the pharmaceutical and outsourcing community with broad strategic and practical knowledge in synthetic organic chemistry, medicinal chemistry, process chemistry,and pharmaceutical development.

Services include:

  • Medicinal Chemistry- expert advice on API lead optimization and selection, including pro drugs
  • API Lead Advancement- syntheticroute assessment and phaseappropriate, “next step”recommendations
  • Outsourcing API and/or leadmolecule development- Vendorselection, technical data packagepreparation
  • Phase appropriate API development strategy- Synthetic route, analytical requirements, and specifications
  • Document review for proprietary datarooms; regulatory filings
  • Due diligence for in-licensing or out licensing opportunities
  • Biodegradable polymers and other novel,custom excipients and linkers- Outsourcing anddevelopment strategy
  • API vendor management andtechnical capability assessment
  • Vendor bid review, contract preparation, and API outsourcing project management

Clinical Trial Consulting

National Institute of Clinical Research’s Clinical Trial Consulting division is an innovative, international drug and device development organization that delivers the full spectrum in consulting from bench to commercialization.

Clinical Trial Consulting focuses on immunology, and with a passion for helping life-changing therapies success in chronically and critically ill patient populations. The team’s therapeutic approach provides pharmaceutical, biotechnology, and start-up firms with an expertise in clinical trials comprised of a unique mix of specialists from the following fields: academic, medical industry, nephrology, endocrinology, hematology, and cardiology.

To strengthen the success potential of your program, Clinical Trial Consulting excels in providing flexible study designs to accelerate development programs that deliver high approval ratings, exceptional global project management, a gold standard in safety, and data management systems.

FDA Consulting

NICR’s consulting team includes extensive experience with FDA affairs. The members’ are of expertise includes: human and veterinary medicine, toxicology, chemistry, pharmacokinetics, pharmacology, microbiology, statistics, and bioequivalence. NICR’s consulting team also consists of experts specialized in FDA medical device approval.

Our team works closely with your management to ensure that you are prepared for the FDA – from the initial gap analysis to implementation and as far as the planning to the continuous improvement of quality control. The motto is to ‘ensure everything is done right the first time.

Assistance with submission of an IND or IDE application• Preparation, coordination, facilitation, or attendance of FDA meetings• Preparation and management for IRB applications• Preparation and management of FDA annual reports• Preparation for, and regulatory support during, FDA inspection of investigator based clinical trial research sites.