Advancing Therapeutics Through Pivotal Regulatory Affairs Approvals
Maintain progress as your program reaches pivotal regulatory stages by engaging our experts to identify, prepare, and submit the appropriate materials to regulators. We provide expert insights on the best pathways forward to ensure adequate funding and technical support. With drug development being such an extensive, detail-oriented process, partnering with world-class regulatory affairs consultants helps safeguard your progress and maintain efficiency.
The 505(b)(2) Marketing Approval Pathway
In our newest whitepaper, experts review regulatory approval pathways and expands on the Food and Drug Administration’s (FDA) 505(b)(2) New Drug Application (NDA) Approval Pathway. If your program innovates products already on the market, there may be opportunities to conserve resources with insights outlined in this free resource.
Pharmaceutical Regulatory Affairs Services
Our understanding of the domestic and international regulatory challenges facing biotech and pharmaceutical operations enables our experts to provide comprehensive support across the drug development pipeline.
Leverage our expertise in drug development for pharmaceuticals, biologics, gene therapies and drug-device combination products. Our team has extensive knowledge in the US and EU regulations.
- Regulatory Advisory Consulting
- Gap Analysis
- Feasibility Assessment
- CMC Consulting
Determine the best path forward for your therapeutic or device. Our consultants provide insights to guide you through designations that support your program.
- Orphan Drug Designation and Annual Reports (FDA and EMA)
- Rare Pediatric Disease Designation
- Regenerative Medicine Advanced Therapy Designation
- Qualified Infectious Disease Product Designation
- Expedited Programs
- ○ Fast Track Designation
- ○ Breakthrough Therapy Designation
Be ready for your engagement with regulatory agencies such as the FDA and EMA. From developing regulatory strategy and authoring meeting requests/briefing packages to meeting preparation and attendance, we provide the level of support you need.
- Formal Meetings with FDA Type A, B, C, D
- Pre-IND Meeting
- End of Phase 2 (EOP2) Meeting
- Pre-NDA Meeting / Pre-BLA Meeting
- INTERACT Meeting
Garner in-depth guidance for your regulatory applications, including authoring of regulatory documents and in-house publishing capabilities. Our team of experts provide full writing and publishing support as well as content, QC, and formatting review.
- Authoring Regulatory Documents
- Investigational New Drug Application (IND)
- Biologic License Application (BLA)
- New Drug Application (NDA)
- 505(b)(2) NDA Application
Submit your regulatory documents to the FDA Electronic Submission Gateway (ESG) portal with confidence. We support application preparation including document compilation, metadata hyperlinking, lifecycle management, and technical validation.
- Initial INDs
- Annual Reports and/or Development Safety Update Reports (DSUR)
- Meeting Requests and Briefing Packages
- CMC Amendments and Protocol Amendments
- Safety Reporting
On-Demand Webinars
Navigating The Investigational New Drug Application Process
FDA eCTD Submissions: Compilation and Publishing
Obtaining Orphan Drug Designations in the US and the EU for Rare Disease Treatments
Overview of FDA’s Expedited Programs for Serious Conditions
Regulatory Affairs Resources
Our regulatory affairs consultants offer a wide range of educational resources to explore the approval pathways, specialty designations, and other unique programs that could benefit your product acceptance and approval. Check out our resource library to access the full breadth of guidance available to you.
Qualified Infectious Disease Product (QIDP) Designation
The Investigational New Drug Process
FDA's Regenerative Mediciine Advanced Therapy (RMAT) Program
FDA Rare Pediatric Disease Designation
FDA Orphan Drug Designation
FDA Breakthrough Therapy Designation
Fast Track Designation
EMA Orphan Drug Designation
eCTD-Compliant Publishing and Submissions
The 505(b)(2) Marketing Approval Pathway
View our Full Resource Library
Keeping Pace® with Pharma
Discover unique insights across a variety of topics to meet milestones, achieve regulatory compliance,
and relieve internal constraints.