Our Network of Consultants

Connecting You With Life Science Experts

Life Science consultants for your project

Welcome to our specialised platform of top-tier consultants, all experts who have worked with biotech and life science companies for many years. Our dynamic platform has been carefully crafted to simplify your journey through the world of consultancy. Take full advantage of the intuitive filters to fine-tune your search and discover the perfect consultant who aligns with your unique project needs. Once you've identified the ideal consultant, the next step is easy – simply select "Start Your Project." You'll be prompted to complete a form with essential project details, allowing us to get a clear picture of your requirements. After you've submitted the form, we'll reach out to propose suitable dates for a kick-off meeting between you and your chosen consultant.

uk

SCICON: 1639

  • Director, Principal Consultant
  • Our consultants have extensive experience of working within start-up and small company environments and have developed their skills and expertise across a variety of disciplines within the IVD industry including, quality assurance, regulatory affairs, design and development, innovation, manufacturing and Notified Body lead auditing.

    Our credentials include the preparation and management of international regulatory submissions, QMS implementation and maintenance in compliance with global regulatory requirements and the successful development and commercialisation of IVD products within entrepreneurial settings.

    Noteworthy former senior leadership roles within pioneering IVD companies include Head of Quality Assurance and Regulatory Affairs, Chief Technology Officer, Head of Site and Director of Innovation and New Technologies.

    We offer a range of pragmatic, flexible and customised consulting and training services covering regulatory, quality, product development and innovation to support our clients from product concept to commercialisation and beyond. These include:
    • Person Responsible for Regulatory Compliance (PRCC).
    • Product classification and regulatory strategy.
    • Performance evaluation planning and reporting, including scientific validity, analytical performance and clinical performance.
    • Risk management (ISO 14971).
    • Preparation of regulatory submissions in compliance with the UK MDR, EU IVDR and other global regulations.
    • Technical documentation review and remediation.
    • Review of marketing, product packaging, labelling and instructions for use to ensure compliance with global requirements.
    • Post-market surveillance and vigilance guidance.
    • Gap analysis.
    • Identification of applicable standards.
    • QMS implementation, remediation and maintenance in conformity with ISO 13485, MDSAP and other global requirements.
    • Quality planning guidance, including quality objectives and management of changes to the QMS.
    • Quality impact assessment of design and development activities.
    • Manufacturing and QC documentation guidance.
    • Supplier control, including the control of critical outsourced processes.
    • Equipment and QMS software validation guidance.
    • Control of nonconformities, including root cause analysis, corrective action and preventive action.
    • Management review.
    • Internal auditing and gap analysis.
    • Innovation input to new product concepts.
    • Evaluation of novel technologies for IVD applications.

    Expertise:

  • Life Science
  • Regulatory
  • Applications:

  • Assay Kits
  • Molecular Biology
  • PCR
  • Scientific Industry:

  • Biotechnology
  • Diagnostics
  • Molecular Biology
  • Research Reagents
  • Products:

  • Assay Kits
  • Diagnostic devices
  • In Vitro Reagents
  • Molecular Biology