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.

Services For Your Lab  /  FDA Regulatory Consulting

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.

Early-phase consulting

REGULATORY STRATEGY

Leverage our expertise in R&D and early-stage development.

Drugs, Biologics, Gene Therapies, Drug-Device Combination Products, & Medical Devices
US, Canada, EU, Asia, & The Rest Of The World
GUIDANCE ON PATHWAYS

Determine your path forward with insight provided by our consultants. We provide insight on:

Expedited Pathways
Project Management Of Cross-Functional Teams For Investigational New Drug (IND) Development
SUPPORT WITH AGENCY

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:

Formal Meetings With FDA, Type B
Pre-IND Discussions
End Of Phase 2 (EOP2) Support
Pre-NDA / Pre-BLA
Formal Meetings With FDA, Type C
AUTHORING

Ensuring your application or submission represents your work accurately and thoroughly often requires an extra set of eyes. Our consultants can support:

Technical Authoring Or Review Of Regulatory Submissions
Orphan Drug Applications

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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.

biopharmaceutical

CDMO Services