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Chemistry, manufacturing and controls
Beckloff Associates prepares and reviews manufacturing information to support analytical methodologies for drug substances and drug products, which are used in the preparation of various regulatory submissions. 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 solutions, 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
- Process evaluation
- Vendor qualification programs
- Analytical methods transfer
- Drug Master Files (DMFs)
- CMC sections of INDs and NDAs
- International regulatory submissions (EDMF, CDMF, IND, NDS, Certificate of Suitability)
- Electronic submissions
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
- Identification, selection, and management of clinical and commercial supplies manufacturers and packagers
- Identification, selection, and management of testing laboratories
- Technology transfer
For capabilities that will meet your needs, and outcomes that will exceed your expectations, partner with Beckloff Associates today. For more information, fill out our Contact us form or call a member of our sales staff at 913.451.3955.
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