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Entering the US market
Achieve US success with confidence
Achieve US success for all types of products, across all stages of development, leveraging regulatory strategy, FDA submission compliance, and effective partnering with the FDA
KEY FIGURES
30+
Years of experience with the FDA
20+
US expedited program applications in the past 3 years
200+
Health authority interactions in the past 3 years
>90%
Consultants with a PhD/M.Sc/Pharm D.
SOLUTIONS
Preclinical
Early-stage clinical development
Late-stage clinical development
Registration & Post-Approval
- FDA early interaction, such as INTERACT and Pre-IND meeting preparation and engagement
- Assessment of eligibility for FDA expedited programs and Orphan Drug Designation (ODD)
- Design nonclinical development plan
- Development of CMC strategy including raw material sourcing and initial process development
- IND preparation & submission
- FDA interactions
- Assessment of eligibility for FDA expedited programs and Orphan Drug Designation (ODD)
- Strategy for manufacturing processes scale-up
- Development and validation of analytical methods to support clinical supply
- Design and implement a GCP-compliant safety system for clinical trials
- Early engagement with payers
- FDA interactions
- NDA/BLA planning
- Application and support for accelerated approval
- Pivotal study design and implementation
- Preparation of Module 3 (CMC) of the Common Technical Document (CTD) for regulatory submissions
- Design and set up comprehensive Risk Management Plan (RMP)
- Value dossier & core economic models, as well as pricing strategy
- Define post-approval strategy
- Submission and review for labeling
- Support for post-approval meetings with FDA, including address PMRs and PMCs
- Lifecycle management, including post-approval CMC changes, labeling updates, new indications, etc.
- Establish a post-marketing safety system
- RWE generation to support long-term market positioning and value demonstration
Strong history of successful interactions with FDA
We provide forward-thinking regulatory strategy and operational support anticipating regulatory needs beyond published FDA guidance, positioning your product for success on the US market.
In-house interdisciplinary expertise
Our expertise spans from preclinical development to post-approval compliance with in-house resources.
FAQs
What are the differences in how the FDA and EMA assess dossiers that are nearly identical in a CTD approach?
While diseases have common physiology, development requirements and regulatory approaches may not be the same. The FDA and EMA should not be considered similar in their evaluation methods or requirements.
Any differences between the regions in approvable endpoints, comparators (drugs), and clinical practice must be resolved at the end of Phase II meeting and/or a strategy for the design and analysis of Phase III trials must be determined and agreed with the health authority.
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What are the key considerations for a pharmaceutical launch?
No two development programs are alike. For 85% of pharmaceutical launches, the product trajectory is set in the first six months.
1. Understand the end goal and specific product requirements
2. Rely on science and experience – strong scientific rationale most often wins
3. Strong relationships and appropriate interactions with health authorities can reduce development timelines
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Related Glossary
Food and Drug Administration (FDA or USFDA)
Pre-Submission Meeting
IND
Biologic License Application (BLA)
INitial Targeted Engagement for Regulatory Advice (INTERACT) meeting
Formal Meetings with FDA
Type C Meeting
Discover our other markets
Questions? Get the answers from our expert team
No two product development paths are the same. Talk to our experts about your development challenges and we will provide you actionable recommendations.