REGULATORY & COMPLIANCE
FDA Regulatory Consulting
From early strategy discussions and meetings with agencies to submissions and applications support on through commercialization, we help our clients with regulatory, compliance, validations, training, and auditing support.
Our understanding of domestic and international biotech and pharmaceutical operations and of the regulatory challenges facing these industries allows our experts to provide comprehensive support across the drug development pipeline.
Leverage our expertise in R&D and early-stage development.
Determine your path forward with insight provided by our consultants. We provide insight on:
Our consultants are here to offer guidance in meetings with US, EU, and international regulators. We can provide guidance on strategy, process and submission packages, and support formal meetings, such as Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products:
Ensuring your application or submission represents your work accurately and thoroughly often requires an extra set of eyes. Our consultants can support:
eCTD-Compliant Publishing & Submissions
How Consulting Firms Assist The IND Process
FDA Orphan Drug Designation
Keeping Pace® with Pharma
Discover unique insights to meet milestones, achieve regulatory compliance, and relieve internal constraints.
CMC Pharmaceutical Development
When your team needs additional CDMO support, our scientists are ready. Our state-of-the-art facilities and highly trained experts can add power to your project.