Chemistry, manufacturing and controls

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Beckloff Associates prepares and reviews manufacturing information, and analytical methodologies, which are used in the preparation of various regulatory submissions for drug substances and drug products. Our objective is to ensure the quality, consistency, and technical validity of the documentation, and to conform to the various regulatory requirements and quality standards. Routinely named as the U.S. Agent for maintenance of these regulatory files, Beckloff Associates works closely with our clients to provide the regulatory authorities with any additional chemistry and manufacturing information necessary for approval.

Beckloff Associates has experience with complete formulation development programs, from the development phase to the production of clinical and commercial supplies, for tablets, capsules, injections, sterile solutions, sterile powders, topical creams, inhalation products, etc., for new chemical entities as well as generic compounds. We have also assisted with identification, selection, qualification, and management of drug substance and drug product manufacturers, testing laboratories, labelers and packagers for the production of clinical (Phase I-III) and commercial supplies.

Our service offerings include:

Chemistry, Manufacturing, and Controls

  • Analytical methods development and validation consultation
  • Regulatory specification development
  • Stability study design
  • Physicochemical characterization and structure elucidation consultation
  • Process evaluation
  • Vendor qualification programs
  • Development of technical transfer packages (manufacturing and analytical methods)
  • Drug Master Files (DMFs)
  • CMC sections of global regulatory submissions
  • Global regulatory submissions (EDMF, CDMF, IND, NDS, Certificate of Suitability)
  • Post-approval support and guidance (Annual Reports, PAS, CBE, Type I and II variations)

Formulation Development

  • Preformulation study design
  • Formulation optimization
  • Manufacturing process development and optimization
  • Development report preparation
  • Process validation design and report preparation

Contract Manufacturing, Packaging, and Testing

  • Identification, selection, and management of drug substance and drug product manufacturers and packagers (Clinical and Commercial supplies)
  • Identification, selection, and management of testing laboratories
  • Technology transfer