FDA Regulatory Consulting Services
FromPace Analytical
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.
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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