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Drug Product Consulting

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CMC provides technical consulting expertise to the pharmaceutical and biotech industry, and our extensive and collective experiences provide us the ability to provide valuable input on a broad range of topics. Our consulting projects have included both very short term and multi-year projects:

Our new and modern 700 square foot wet chemistry development lab is equipped to execute both routine and unique drug product development studies. We customize our drug product development studies for each client. Our current focus is:

Pre-formulation and formulation selection and design

The physical and chemical properties of an active pharmaceutical ingredient are critical in the selection of a dosage form. CMC can evaluate existing data and provide a recommendation for an experimental plan and/or a development plan to prepare drug product for pre-clinical or clinical studies. organization network that can produce cGMP drug products for worldwide distribution for clinical studies and commercial use.

Drug Product Supply Chain

CMC has established and maintained clinical and commercial supply chains for virtual pharmaceutical companies for a wide variety of products that include oral solids and liquids, sterile injectables. We are particularly experienced with cold chain requirements.

Regulatory Filings

Authoring & review of CMC regulatory filings is one of our core competencies. We have extensive experience in preparing drug product documents for INDs, NDAs, FDA queries, supplements and amendments, annual reports, site inspection observations, 483’s and warning letters.

Technical Business support

CMC has provided clients with technical support during due diligence for product out- and in-licensing as well as technical support for M&A activities. We have also provided business development support for technologies that require extensive technical interactions.

Drug Product Development

Formulation and process development plans have been prepared for clients to move their pharmaceutical pipeline forward in a timely manner.

Project teams

The successful development of a pharmaceutical product requires a well functioning project team. CMC has provided significant expertise and contributed to virtual product development and manufacturing teams. Providing decades of experience in a cost effective manner for a project can significantly reduce overall costs while expediting development.

Analytical characterization

The FDA requires significant analytical and stability characterization for every drug product. We can evaluate and generate the appropriate analytical plan for each stage of development. Our extensive trouble shooting experience can prove invaluable when unexpected data or results are observed or generated.

Drug Product instructions

Dosage preparation instructions are required for INDs, NDAs, non-clinical and clinical protocols, and investigator’s brochures. We have extensive experience in reviewing and preparing these documents.