Whether you need an expert regulatory affairs strategist to develop the optimal pathway to drug approval, need an experienced regulatory writer or medical writer or just need assistance with regulatory information management and eCTD regulatory submissions, our comprehensive services are designed to support your business objectives.
Regulatory Affairs Strategy
Obtain expert regulatory affairs strategy assistance to develop a roadmap and maximize available health authority benefits, timing, and feedback/interactions.
Regulatory Writing
Ensure your regulatory documents are compiled as required by the regulatory guidance and detailed to ensure a positive outcome with health authorities.
Medical Writing
Ensure your clinical trial documents present the relevant information accurately, and in a clear format that is easy to understand.
Regulatory Information Management (RIM)
Collect, organize and archive documents related to your regulatory submissions and health authority correspondence for quick access by all key team members.
Regulatory
Intelligence
Monitor and analyze regulatory intelligence to ensure earlier strategic regulatory actions with the potential to reduce product development timeline.
eCTD Submission Management
Leave electronic common technical document (eCTD) filing in the standard submission format for FDA regulatory application submissions to us.