Services: Pharmaceutical Product Development

Our pharmaceutical product development team consists of experts in the areas of chemistry, manufacturing, and controls who provide the technical expertise for the selection and qualification of pharmaceutical active ingredients suppliers, pharmaceutical product development, and dosage form development. In addition, our doctorate-level scientists and other pharmaceutical professionals provide management of the manufacturing, packaging, and labeling of products as well as documentation of clinical trial material. Our in-house specialists have significant experience in oral, topical and parenteral formulations of drug and biological products.

Our CMC team works closely with all other disciplines to ensure products of the highest quality are available for clinical trials in a timely fashion.

Specifically, our CMC Team offers expertise in three major activities:

Technical activities:

  • In the area of managing drug substance and drug product development, we provide preformulation, formulation/scale-up, production planning, stability studies, and specification development
  • In the area of product analytical testing, we provide preformulation testing, formulation testing, in-process testing, release testing, stability testing, and compatibility testing
  • In the area of drug substance evaluation, we provide manufacturing validation, in-process validation, release test validation, and stability testing validation

As we help you coordinate clinical trial material, we will help prepare the manufacturing, packaging, and labeling (MPL) document, the MPL document execution, release of CTM, and documentation review.

Regulatory activities:

  • Development of the CMC section of regulatory submission
  • Attendance and participation at FDA meetings to formulate or clarify product development strategy
  • Review of the design and construction of manufacturing facilities to determine compliance with FDA standards

Corporate development activities:

  • Conduct on-site cGMP and cGLP training and development seminars
  • Creation or review of standard operating procedures