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CMC (Chemistry, Manufacturing & Controls)

Prepare Your Organization for New Product Submission

CMC is a critical component of the drug development process. You need a knowledgeable team who can help you prepare Module 3 of your upcoming product dossier.

Our Team Can Help Prepare Your CMC Submission

OSR offers specialized services for small pharmaceutical companies. Our CMC team members have over 25 years of experience in drug substance; drug product; NDA/BLA authoring; experience with lab, manufacturing, product and process development; biologics and small molecules; and interfacing with interdisciplinary teams (quality, clinical, operations, etc.).

We assist with some of the paramount issues that companies face across all phases of development, including:

  • CMC Module 3 Preparation – This can be a complicated process that must be managed by experienced professionals - especially if your plans involve submissions to multiple countries
  • Regulatory Documentation Changes – From initial clinical trial to pre-registration, registration, post-approval, and through lifecycle, a highly-flexible regulatory strategy is a must
  • Post Approval - Your organization should maintain an effective change control process, along with lifecycle maintenance strategies for any approved pharmaceutical product

OSR Can Help Build a Carefully-Crafted
Drug Manufacturing Strategy

As your drug completes/begins Phase 3, a carefully crafted drug manufacturing strategy around CMC is critical for successful launch and commercialization of your product. Your company may be asking questions in the following areas:

Agency Meetings & Submission Planning:

  • What is the timeline for a meeting with the Agency, including required lead time by the Agency?
  • How do we prepare for meetings with agencies and how do we manage important feedback?
  • Should we request separate presubmission meetings for CMC, Clinical and Non-Clinical, with the Agency?
  • What type of agency meeting(s) should we request and should we request meetings with global agencies?
  • How can I prepare a dossier which maximizes CMC and quality information that can be used in global submissions?
  • Are there differences between the submission of a new biologic and the submission of a new drug differ?

Manufacturing & Testing:

  • How do we move from Clinical to Commercial manufacturing?
  • How do we best identify potential manufacturing and testing facilities for drug substance/product?
  • When do we validate the commercial manufacturing process and what are the regulatory requirements?
  • How much stability data is required and at what conditions?
  • Do stability studies have to be conducted in the intended commercial packaging?
  • Do we really need photostability and thermal degradation studies?
  • What are the restrictions to US versus ex-US manufacturing and testing for global markets?

Expert Advisors at Your Fingertips

Comprehensive assistance for short-term projects or long-term needs.

+1 833-OSR-TEAM