Submission of a registration dossier cannot be considered without a well-defined and validated Regulatory Strategy which includes key components such as compliance with Scientific Guidelines as long as they are available, documentation of competitive claims and product positioning, consideration of the product lifecycle in view of sequential developments, submission priorities and planning, opportunities for accelerated or simplified procedures and interactions with Health Authorities.
- Interaction with Health Authorities
We assist you in establishing productive communications with Health Authorities (French and/or European Agency Consultation, Scientific Advice, Clarification Meetings, Oral Explanation). This includes coaching and assistance in meeting preparation, rehearsal, briefing package, slide set generation and active participation upon request. Communication with Health Authorities helps the validation of the Regulatory Strategy, especially in situations when appropriate scientific guidelines are not available or existing ones must be negotiated.
- Common Technical Document (CTD)
We write the different components of the CTD (integrated clinical summaries and overviews) in a ‘friendly reader’ manner with the purpose of facilitating the evaluation with concise presentation of the data in the summaries and relevant discussions in the overviews.
- Summary of Product Characteristics (SPC)
Support to the development of the Summary of Product Characteristics (SPC) in accordance with the CCDS/CCSI with the purpose of optimising both efficacy and safety label claims.
- Evaluation Procedure
We can handle the Questions-and-Answers process at each step of the evaluation procedure.