Dendritic cell vaccine (oncology)

  • Small biotech US company developing a dendritic cell vaccine for the treatment of the Orphan indication glioblastoma in EU
  • Timeline: long-term (8 years)
  • Support in

-Preparation and conduct of the Scientific Advices (SA)

-Medical and technical Writing

-Clinical trial Phase III

-Adaptive pathway

-Early access medicines scheme (UK)

-Hospital exemption (DE)

-Pediatric Investigational Plan (PIP)

-Pharmacovigilance: DSUR and PSUR

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Regulatory CMC Compliance reduced risk

  • Identified deficiencies in Change Control procedures and GMP manufacturing documentation
  • Uncertainty in verifying the current registered information held with Health Authorities
  • Lack of Regulatory Information Management (RIM) systems and therefore lack of oversight of product information for key stakeholders

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Definition of batches internal release limits based on stability results

A client faces multiple batch rejection due to outdated Internal Release Limits (IRLs) but he has 100+ products (500+ attributes) to analyze and follow up on a regular basis

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Lifecycle management for drug products

Reluctance to compute tolerance intervals

  • Needed support with the preparation of Module 3 and corresponding Module 2.3 documents for drug substances and drug products:
    • To reflect the current status of manufacturing process and state of the scientific art analytical procedures
    • To close gaps and achieve GMP compliance of regulatory documentation.
  • Required on-going lifecycle management for all drug product licences needed.

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Multi-country Phase III clinical trial support

Market specific CTA applications for a multi-country EU Phase III clinical trial

  • Assistance required to review core documentation.
  • Authoring of local documentation for country specific submissions.
  • Assistance with competent authority and ethics committee communication.
  • Support with handling of substantial amendments to competent authorities and ethics committees, as required.

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US-UK Phase II clinical trial support

Support for timely approval of a Phase II clinical trial in the US and UK

  • Required assistance in IND authoring, eCTD publishing and FDA Agent activities for submission to FDA.
  • Alongside support in authoring of IMPD and local documentation required for submission to MHRA.

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