Obtaining the correct agency advice from experienced regulatory affairs consultants is a critical part of the product development and market approval process. Aptiv Solutions regulatory experts have significant experience in interacting with regulatory agencies in North America, Europe, Japan and ROW.
Using an efficient process to identify the critical issues that need to be discussed, and supported by preclinical, CMC and medical experts, comprehensive briefing documents are produced and submitted to the regulatory agencies to guide appropriate discussion. Aptiv Solutions regulatory team has experience in all types of agency meetings:
Regulatory Affairs Consultants Agency Expertise:
- Pre-IND meetings
- End-of-phase 1 and end-of-phase 2 meetings
- Special protocol assistance
- Scientific advice: EMA and National
- Orphan drug pre-submission meetings
- PMDA consultation
- MAA pre-submission meetings
- PIP consultation
- Request for designation
Specific support for Adaptive Clinical Trials
The combination of Aptiv Solutions regulatory experience in seeking agency advice with Aptiv Solutions adaptive trial design expertise can greatly facilitate the process for gaining regulatory approval for simple and complex adaptive trials.