Development and Commercialization

 

Development and Commercialization

 

Development and Commercialization

 

  • Enjoy expert services from start to finish.

    Put our proven track record in pharmaceutical product development and world class global manufacturing facilities for inhaled, transdermal, oral and topical dosage forms to work for you.

    From early feasibility studies and initial product development to clinical supplies and scale-up for commercial manufacturing, you’ll benefit from our robust processes and streamlined operations.

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  • Product development: the 3M process

    Depend on support through every step of the product commercialization process from our team boasting experience, global capacity, and extensive quality and regulatory expertise. We can rapidly screen one or more compounds for compatibility with one of our drug delivery technologies.

    We then evaluate formulation, process and component variables in the feasibility phase. Results of our feasibility studies provide our partners with confidence in moving forward together to full product development and commercial supply stages.

  • Full range of cGMP compliant services

    • Toxicology, clinical and commercial supplies
    • Scale-up and registration support
    • Analytical method development and validation
    • Raw material and finished product testing
    • ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) and custom stability programs
    • Flexible, commercial high speed packaging lines
    • MDI pressure- and cold-filling capabilities
    • Potent and controlled substance compound handling

     

  • Commitment to Quality and Improvement

    • Lean Six Sigma manufacturing
    • Product process understanding
    • Global standard operating procedures
    • Latest process analytical technology
    • Global electronic systems for Issue Management
    • Accredited quality professionals

     

  • Regulatory Expertise and Global Compliance

    • Excellent regulatory history for the US and global product submissions (IND, ANDA, NDA, DMF, CE Mark Technical File and others)
    • Experience ranging from sponsoring entire submissions to preparing Chemistry, Manufacturing and Controls (CMC) packages
    • Registrations and accreditations include: ISO 14001 Environmental Systems; Japanese Accreditation to Revised Japanese Pharma Law

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