Regulatory CMC

CMC strategies

Reduce approval times and simplify the burden of post-approval work.

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CMC strategy, authoring and reviews

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

Why use our support with CMC strategies?

  • 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

 
More regulatory CMC services

CMC project management
Technical advice and support
CMC documentation management
Formulation advice and support

Your contact person

Erik Hedner

www.arexadvisor.com

Arex Advisor AB

  • Sveavägen 9,
  • 111 57 Stockholm
  • Sweden

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Staffan Thunell

Founding partner

BSc Economics and BA

Staffan has a long background in entrepreneurship within the life science industry. He has 20+ years experience from posit­ions as Founder, Chair­man, CEO and CFO within medical affairs consulting and small pharma. Previously Staffan worked in executive positions in big pharma and specialty pharma companies.