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Voisin Consulting Life Sciences

Regions
Europe, North America, …
Regions
Europe, North America, Asia
Countries
France, India, …
Countries
France, India, Singapore, Switzerland, United Kingdom, United States
Size
100-250
Specialty
Human Medicines, Biopharmaceuticals, …
Specialty
Human Medicines, Biopharmaceuticals, Medical Devices
Service category
Regulatory services - CMC writing - medical writing
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Key services

Services

 

Regulatory Services

With a particular focus on science-based regulatory strategy and not simply regulatory affairs, Voisin Consulting Life Sciences drafts, reviews, compiles and submits a broad range of submissions to international Regulatory Agencies and Competent Authorities. Our global knowledge and local presence are key success factors.

You will find more details on the specific types of submissions in the corresponding pages of the products section.

  • Harmonized global regulatory strategies based on science and risk management
  • Identification of regulatory risks & how to control them
  • Collaboration with Regulatory Agencies and Competent Authorities

Clinical Development

Our local offices assist clients with the implementation and management of international clinical programs, including safety reporting. We also assist with US Agent and EU legal representation activities. In the USA, we provide full US Agent services, including IND maintenance under eCTD format.

Our expertise encompasses clinical development for a broad range of products, study populations and indications. Study populations span from pediatric to elderly. A specific expertise has been developed on cell, gene and tissue therapies using a methodology based on risk assessment.

Our project teams interact with external clinical Experts, Key Opinion Leaders and CROs.

  • Design and implementation of clinical trial programs considering immediate and long-term global development goals
  • Protocol design, IB, IMPD, PIL and ICF
  • Preparation, submission and maintenance of clinical trial applications
  • Support for EU legal representation
  • US Agent for INDs and IDEs

Drug Safety/Vigilance

  • Pre- and Post-marketing integrated Pharmacovigilance services
  • Medical expertise provided by internal EU Qualified Person for Pharmacovigilance (EU QPPV)
  • Constant monitoring and evaluation of the Risk/Benefit ratio of the product.

Drug Safety and Pharmacovigilance Services

  • Preparation of customized drug safety and pharmacovigilance SOPs
  • Registration of Sponsors in the EMEA EudraVigilance database
  • Registration of medicinal products in the EVMPD
  • Third Party Service Provider as a service
  • Individual Case Safety Reports (ICSRs)
  • EVMPD information to EudraVigilance via EV WEB
  • SAE coding, management and Expedited reporting: Collection, Quality Control, Assessment, narrative writing, unblinding and management of ICSRs
  • Periodic Safety Reporting: clinical trials Annual Safety Reports, IND reports, EAP Periodic Safety Reports and PSURs
  • Preparation of MAA module 1.8.1 and 1.8.2: Risk Management Plans including Pharmacovigilance Plan, Pharmacovigilance System Description.
  • Participation in global safety meetings with the Competent Authorities
  • Review of safety sections of promotional material
  • Safety training of Medical Science Liaisons and Sales Teams.

Medical Device Vigilance Services

  • Pre and post-marketing vigilance services for all classes of Medical Devices according to the European guideline MEDDEV 2.12-1 rev. 5, including:
  • Preparation of customized Standard Operating Procedures (SOPs) for Medical Device Vigilance system and Incidents / Near Incidents reporting procedures.
  • Incidents/Near Incidents management: Cases reception, Quality Control Assessment, and preparation of narratives
  • Incidents / Near Incidents Expedited Reporting: Preparation and submission of Manufacturer Incident Reports and Field Safety Notice (FSN) to multiple Regulatory Authorities where necessary.
  • Periodic Vigilance Reports: Complete and submit Periodic Summary / Trend Reports to National Competent Authority

CMC/Quality

Voisin Consulting Life Sciences proposes complementary CMC and Regulatory services and provides expertise to fulfill the various Quality sections of regulatory filings such as Module 3 of the CTD following EU and US requirements.

We believe that effective product development requires strong technical background and robust regulatory expertise. Our CMC group was therefore built with team members having significant pharma/biotech industry experience in product development, technology transfer, analytical development, Quality Control and CMC regulatory affairs. This makes us well prepared to interface efficiently with the technical and regulatory teams and help coordinate CMC activities in line with the development phases of our client’s programs.

Technical support

  • Management of complete technology transfer projects
  • Coordination of manufacturing and method transfer
  • Identification of Contract Manufacturing Organizations and analytical laboratories
  • Support with writing Qualification and Validation protocols and reports
  • Assessment of Quality Systems and compliance with cGMP.

We become part of our client’s team and interface with all parties involved in the program to ensure that appropriate information is generated and effectively utilized.

Regulatory support

  • Pharmaceutical sections of IMPDs for Clinical Trial Applications
  • Module 3 and 2.3 of MAA, BLA or NDA submissions
  • Briefing packages for Scientific Advice or Protocol Assistance
  • Participation in Agency meetings at all stages of development
  • Design of comparability strategies
  • Viral Safety assessment for biological products.

Overall, we approach CMC development in a pragmatic manner adapted to each product’s complexity, taking into account the evolving quality and regulatory paradigms and keeping in mind similarities and differences between regions.

Expanded Access Programs

Voisin Consulting Life Sciences advises on Expanded Access Programs (EAP), also known as:

  • Early access
  • Compassionate use
  • Autorisation Temporaire d’Utilisation (ATU) in France
  • Law 648/96 in Italy
  • Design and implementation of Expanded Access Programs
  • Preparation of global strategic plans
  • Protocols for therapeutic use (PTU)
  • EAP-specific Summary of Product Characteristics (SmPC)
  • EAP-specific Case Report Forms (CRF)

Electronic Submissions: eCTD/NEES

Voisin Consulting Life Sciences was among the first applicants to submit an electronic application as eCTD in 2006. We help you:

  • Understand and manage your e-submissions, whether eCTD or Non-eCTD Electronic Submission (NEES)
  • Define or review the backbone and structure of your submissions prior to writing
  • Assess your eCTD or NEES applications for compliance prior to submission
  • Provide guidance on national specificities
  • Prepare eCTD or NEES submissions from core document writing to filing
  • Answer ad-hoc questions.

Approvals, Certificates, Authorisations

  • ISO 9001:2008

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