FDA Regulatory
Effectively navigating the investigational and new drug, device and biologics regulatory pathways and clinical research regulations is a critical element in the successful development of your product.
During each stage of development, you face issues with drug and medical device regulations that can potentially impact your product timelines and chance of gaining regulatory approval. At Emmes, we understand your challenges in clinical product development and provide proactive guidance to mitigate development and regulatory risk with regards to FDA regulations for drugs and medical devices.
As your collaborative partner, we are committed to providing you with guidance on FDA regulatory and schedule issues, milestone-based delivery timelines that decrease your time-to-market, and novel approaches to optimize your product’s development schedule. Whether you need regulatory strategy, operational support or medical/regulatory writing assistance, Emmes welcomes the opportunity to partner with you throughout your product development lifecycle.
International Regulatory Support
With offices throughout the world, including the US, Canada, Europe, and India, Emmes offers expertise in country-specific regulatory submissions as well as regional regulatory requirements. Capable of providing support for coordinated operational submissions across multiple countries, we help companies seeking ex-U.S. authorization for their investigational new drugs as well as companies abroad seeking product clearance, licensure or approval in the US.
Regulatory Affairs Services
Emmes offers a range of services to satisfy your full-service or functional outsourcing requirements for drug and medical device regulatory affairs.
Regulatory Strategy Support
- Strategy and planning
- FDA pre-meeting package preparation, discussions, and panel participation
- Document preparation for IND, NDA, and BLA as well as CTDs and Drug Master Files
- Clinical protocol development
- Module 2 summary sections
- Investigator brochure preparation
- Clinical study and annual report preparation
- CMC support and management
Product Development
- Gap analysis, target product profile and product development planning
- Integrated project teams to inform clients on regulatory requirements
- Regulatory communication and risk management planning
