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Expertise

Regulatory Strategy & Submissions

Design and implementation of global patient-centric regulatory strategies to ensure expedited product development and commercialization.

Powered by a team with extensive FDA, EMA and national Regulatory Agency experience, including former regulators, VCLS advises life sciences HealthTech companies to develop effective strategies to bring innovative technologies from early phase through to the post-market with the prospect of long-term service.

Every client case is different and has its own particular needs. At VCLS, we act as the extension of your product development team and offer customized solutions.

Integrated operations bridging over the Atlantic

Our experts in Europe and the US work within a project matrix team to provide our clients with coherent regulatory strategies and operational support that cover the full range of activities from early preclinical development to marketing authorization and product lifecycle management, by navigating through the FDA and EU agencies interactions.

Global Regulatory Strategy & Roadmaps

Gap analysis
Integrated product development planning and execution
Target Product Profile (TPP)
Product positioning
Pre-approval and post-approval regulatory pathway
Due diligence
Access to Market
Create and review regulatory dossier with patient insights

Global Regulatory Preparation & Submissions

MAA NDA / BLA
Clinical Trial Applications (INDs, CTAs, CTNs, etc.)
CE-marking technical files
Integration of HTA insights
Pre-approval submission (Scientific Advise, CTA, variations, Type B meetings, etc.)

Regulatory Agency Interaction

EMA and National Scientific Advice procedures
Pre-IND, EOP2 meetings, pre-NDA/BLA meetings
EMA SME meetings
ITF meetings
EMA/HTA parallel consultation
PRIME/BTD/RMAT
ODD
PIP/PSP
Regulatory agency interactions with patient groups

Regulatory Lifecycle Management

Strategy and implementation
Post-approval lifecycle management including variations, amendments, renewals, supplements and annual reports

Complemented by:

SME status
US agent
ODD sponsor

F.A.Q

What is Scientific Advice (SA)?

Scientific advice is when the Agency gives advice to a developer on the appropriate tests and studies in the development of a medicine. It facilitates the development and availability of high-quality, effective and acceptably safe medicines, for the benefit of patients.

There are 7 different Scientific Advice procedures :

- EMA Scientific Advice / Protocol Assistance
- National Scientific Advice
- Briefing meeting with ITF
- SME briefing meeting
- PIP Scientific Advice
- EMA/HTA Parallel Consultation
- EMA/FDA Parallel Scientific Advice

What is an INTERACT meeting with the FDA?

The INTERACT meeting can be used to help facilitate more efficient product development by enabling sponsor-investigators to obtain preliminary, informal consultation with CBER prior to requesting a pre-IND meeting. Sponsor-investigators can obtain non-binding advice regarding:

Planning initial clinical development strategies
Chemistry, manufacturing and controls (or CMC)
Pharmacology/Toxicology
Clinical aspects of the product development program

An INTERACT meeting is not intended to take the place of a pre-IND meeting nor is it a prerequisite to requesting a pre-IND meeting.

Why request an INTERACT meeting?

If you are a sponsor-investigator conducting early product characterization and preclinical proof-of-concept studies and/or you want to initiate discussion for a new delivery device, you should request an INTERACT meeting.

If you are seeking to obtain information on overall early-phase clinical design elements or you want to identify critical issues to address in the development of new and innovative products early in product development, you should request an INTERACT meeting.

Regulatory Strategy & Submissions