Need a regulatory strategy, for a new registration or for a complex life cycle management project? A due diligence? A meeting with authorities for a scientific advice?
Thanks to our 20 years of experience, we support you in your regulatory procedures for, among other things:
- A request for scientific advice with the authorities
- A regulatory strategy for a new registration or for complex CMC projects, with risks identification and remediations,
- An application for a marketing authorization in CP, DCP, MRP or national, a geographical expansion project,
- Submissions of variations, license renewal, line extension,
- A file remediation or a reformatting into CTD format,
- A regulatory contribution for your multidisciplinary projects (quality assurance and control, production, packaging, distribution), aligned with your technical and financial objectives,
- An alignment of your labeling with your CCDS, or its update, from the initiation of the change control to the final implementation of the new packaging items,
- An evaluation of a change control, a file review for an MA application or for a remediation
- A due diligence …
