Regulatory Services

Aclairo consultants are experts in FDA regulations and guidelines and provide insight into current regulatory interpretation at the FDA. We support clients in their FDA interactions through written documents, oral communication, and face-to-face meetings. Activities are in our areas of scientific depth: toxicology, pharmacology, pathology, ADME, and clinical pharmacology.

  • Regulatory due diligence
  • Critical review and gap analysis of regulations
  • 505(b)(2) strategies
  • FDA correspondence interpretation and regulatory guidance
  • FDA meeting and teleconference participation
  • Regulatory meeting coaching and preparation
  • Expedited regulatory pathways
  • Strategic product placement
  • Complete response to Clinical Hold
  • Integrated Development Plans

Advyzom

We have a strategic alliance with a world class regulatory group, Advyzom.   They provide experienced regulatory professionals to support global regulatory strategy, FDA liaison roles, clinical medical writing and submissions. www.advyzom.com


For more information, please contact: Hilary Sheevers