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Expertise

Regulatory Strategy & Submissions

Design and implementation of global patient-centric regulatory strategies to ensure expedited product development leading to 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 post-market compliance and expanded opportunities with the prospect of long-term partnering and support.

Every client’s 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 life-cycle 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, regulatory pathways and post-approval reporting categories
  • 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
  • All FDA PDUFA meetings (INTERACT, Type A, Type B, Type C, Type D, Pre-IND, EOP1 and EOP2 meetings, pre-NDA/BLA Meeting Requests, Briefing Packages, Meetings)
  • EMA SME meetings
  • ITF meetings
  • EMA/HTA parallel consultation
  • Leveraging designations (fast track, PRIME/BTD/RMAT)
  • ODD
  • PIP/PSP
  • Regulatory agency interactions leveraging 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

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F.A.Q.

What is Scientific Advice (SA)?

Scientific advice is when a Health Authority 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.

Across US & EU as well as local national authorities, there are many different Scientific Advice procedures / Industry Meetings:

    • FDA INTERACT meetings
    • FDA pre-IND meetings
    • FDA End of Phase (EOP1, EOP2)
    • FDA Type D “follow up”
    • FDA Type C (surrogate endpoints, general advice)
    • FDA pre-registration meeting (pre-NDA, pre-BLA)
    • FDA Special protocol assessment (Phase 3, Carcinogenicity and registration stability)
    • FDA Type A meetings
    • 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

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.

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.

VCLS Expertise

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