Regulatory CMC expertise and support
CMC strategies
Reduce approval times and simplify the burden of post-approval work.
Reduce approval times and simplify the burden of post-approval work.
We assist with authoring, submission review, and offer regulatory strategic advice.
Lead the CMC delivery team in the creation, review and approval of the CMC part of submissions
Provide expertise in defining the technical and CMC documents required for submission
Write and review CMC documentation for consistency and compliance with guidelines and monographs
Coordinate and lead responses to questions on CMC issues from regulatory authorities
Our documentation support will help you create optimal CMC strategies by focusing on the final product characteristics and patient needs. We use the combined knowledge and experience from our team of experts to evaluate the criticalities of your product and applicability of guidelines and regulations for a science based approach market approval.
For example, we may assist you with:
– GAP analysis of existing data versus regulatory requirements
– Defining a Target Product Profile
– Establishment of a regulatory compliant development plan
CMC project management
Technical advice and support
CMC documentation management
Formulation advice and support
Erik Hedner