FDA Regulatory Consultants – Due Diligence

“We don’t have the regulatory resources in-house to ensure product approval.”

“We need to evaluate a potential acquisition, but we’ve never done that before.”

“We’re concerned about the FDA’s increasing scrutiny of our clinical trial execution.”

Compliance Architects® provides the following expert advisory and consulting services:

Product Development / Submissions / Commercialization

  • Regulatory Strategy
  • Pre-Approval Inspections (PAIs)
  • Clinical Compliance
  • Submissions Audits & Opinions
  • Regulatory Advocacy

REMS (Risk Evaluation and Mitigation Strategies) 

Mergers / Acquisitions / Licensing

  • Due diligence operational reviews
  • Target risk assessments
  • Transaction agreement review/drafting