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.

At Emmes, the spirit of collaboration and engagement is omnipresent amongst employees in the Rockville, MD, USA office.

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.

Hematology Experience

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
Contact Us

Regulatory Affairs Leaders

Bob Anderson

Bob Anderson

Associate Vice President, Regulatory Affairs
Kim Wilkinson

Kim Wilkinson

Director, Medical Writing
Eric Hardter

Eric Hardter, Ph.D., RAC (US, CAN, EU)

Regulatory Manager, Regulatory Strategy

Tom Harvey

Manager, Regulatory Operations