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Regulatory Affairs & Product Development Services

The Application of Strong Scientific Understanding

New drug development dossiers (TTPs, CTAs, INDs, IMPDs)

BioVentures Consulting Limited can compile all the essential documentation required in new product development, such as the Target Product Profile (TPP), Clinical Trials Application (CTA) including the Investigational Medicinal Product Dossier (IMPD) and Investigator’s Brochure (IB) in the EU; and Investigational New Drug (IND) in the US. These documents will become pivotal in confirming long-term strategies, and in establishing key phrases and statements which will go on to form key messages for many years to come, throughout the full development, submission and approval.

The Target Product Profile (TPP) is an excellent ‘base document’ which can be used to kick-off the drug development process. It can help focus strategy and serves as a link between development and market considerations in order to assess whether the intended medicinal product is worth developing (in terms of project value). BioVentures Consulting Limited’s expertise in both commercial and drug development documentation makes us ideally placed for compiling TTPs on behalf of clients. We know how to combine clinical attributes, with patient segments, competitors, market positioning and share, sales forecasts, risks and the overall project value sections of the target product profile.

BioVentures Consulting Limited expertise will ensure common questions following review are prevented

BioVentures Consulting Limited can work with clients to create the content of a full Investigational Medicinal Product Dossier (IMPD) in CTD format, with the level of detail appropriate for the stage of development, or a simplified IMPD (sIMPD) for additional trials where abbreviated submissions are possible. BioVentures Consulting Limited expertise will ensure common questions following review are prevented.

For example, with regard to Quality:

  • Is the medicinal product stable at the proposed temperature for the duration of the study?
  • Has the complexity of the manufacturing process been clearly explained? (including responsibilities of 3rd party sites)
  • Is the specification appropriate for the stage of development?
  • Have the analytical methods been adequately described?

With regard to Nonclinical information:

  • Does the dossier support proposed duration of treatment?
  • Is data available to support proposed combinations?
  • Have safety signals been identified, described and addressed?

With regard to Clinical data:

  • What evidence is available that the medicinal product will be efficacious?
  • Have previous submissions demonstrated a side effect profile of concern?
  • How many patients have so far been exposed to the drug?
  • Is a positive benefit / risk anticipated?

The IMPD is a major part of the Clinical Trials Application (CTA), along with the Investigator’s Brochure (IB), and if available, a summary of Scientific Advice from any Member State or the EMA concerning the clinical trial. However, BioVentures Consulting Limited will also consider National requirements (e.g. the need for a translated protocol synopsis for Italy, the CTA to be registered on Afssaps database by local affiliate for France, a separate IMB application form including TSE information for Ireland; and so on). 

A CTA will also require a copy the EMA’s Decision on the Paediatric Investigation Plan (PIP) and the opinion of the Paediatric Committee (if applicable). Thus, BioVentures Consulting Limited can compile and submit the complete Clinical Trials Application (CTA) on your behalf, or can provide practical considerations when compiling CTAs and IMPDs, and consider EU regional differences. We can also manage the response to questions (within 30 days of receipt of questions) and importantly, track commitments. BioVentures Consulting Limited can advise on developments such as the Voluntary Harmonised Procedure (VHP), from the Phase 1 VHP request and validation step, the Phase 2 VHP Scientific Assessment step and the Phase 3 National step; as well as providing advice on the Commission Consultation Document and the EU Clinical Trials Directive.

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