Dr. Kerry Gombatz
Gombatz Consulting, LLC

13 North 3rd Street, #144
Oxford, PA 19363
Phone: (484) 682-4772
E-mail: kerry@gombatz.com
 

Specialties:

Services:

Gombatz Consulting provides supply chain development services and contract management services for outsourced products in the Pharmaceutical Industry. We help develop creative solutions for tactical and strategic sourcing strategies for Pharmaceutical APIs and GMP and non-GMP Intermediates for the Pharma and Biotechnology Industries. We have vast experience for handling materials in all pre-clinical and clinical phases of development and can provide CMC guidance for the successful development and commercial launch of our customers Pharmaceutical products.

Our services concentrate on all development areas for the Pharmaceutical industry.

Supply Chain Development, both short and long term to meet a customer's immediate preclinical and clinical supply needs and the development of long term commercial supply requirements for successful launch and maintenance of a robust supply chain.

Outsourcing of API supply and advanced GMP intermediates for all phases of development to meet your current product development requirements.

Sourcing of raw materials, catalysts, and technology.

Analytical Chemistry ( Specifications, impurity tracking, method development, validation and release).

Evaluation of existing synthetic route for scale-up and long term supply, coordination of any process development activities for current and future campaigns.

Management of new route development programs for long term supply.

Coordination of all analytical requirements with synthetic chemistry route development to fulfill CMC requirements.

Complete Project Management activities.

Chemical Development including new route development, process improvement and modifications, scale up.

Gombatz Consulting can also provide market analysis to facilitate creative strategic and tactical solutions to improve competitive performance, market share, revenue, and bottom-line profitability for new and existing product lines and services.