Step-by-step guidance for agency representation.

Meetings with regulatory agencies are essential and require preparation no matter what stage the product is in its lifecycle. Our team of regulatory consultants and subject matter experts will guide you through the submission process step by step. We ensure strict adherence to FDA and EMA/NCA standards and cover specific regulatory and/or scientific issues arising during early or late-stage development. Through clear communication and thorough preparation, we answer crucial questions and understand expectations to prepare you for regulatory meetings. With years of experience and a diverse team of experts, we will guide you and develop concise strategies to interact successfully with regulatory agencies.

Expertise and excellence in regulatory agency representation

  • We have over 30 years of experience collaborating with the FDA and EMA, participating in countless meetings. 
  • We can save valuable time and resources by implementing early engagement strategies and seeking expert advice.   
  • Our successful track record and expertise ensure strict adherence to FDA and EMA standards, guaranteeing you a successful submission process or agency representation.
  • We have encountered a wide range of scenarios and consistently strive to make meetings run as smoothly as possible. 

We work as a team with many years of experience, ensuring clients receive top-tier guidance and support in their interactions with agencies like the FDA and EMA.

Meranda Parascandola

Head of Business Development and Marketing, North America

Meranda Parascandola