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?