Upon request we can prepare for your discussions with the authorities. This means that we prepare the necessary documents, submit the applications, give you scientific advice with the authorities and support you during the discussions and in the follow-up.
Application for clinical trials
If you wish to submit an application for a clinical trial, we can help with this. We will prepare the required documents (IMPD, IB, IND for US-FDA) and submit the application to the competent authorities. We’ll also help with substantial amendments during the trial.
Gap analyses, expert due diligence, regulatory compliance
For all the available documents in your development process, we’ll perform gap analyses, for example of:
- IMPD and IB
- Non-clinical and clinical trial reports
- Plans and reports on the physical–chemical characterisation of chemical and biological active ingredients, production development, scale-up, stability, compatibility, formulation development, impurity profiles, stability of clinical test preparations
We compile the results from the early stage of the development process in regulation-conform reports and evaluate them in terms of their technical suitability and regulatory compliance.
Types of marketing authorisations
We are entrusted with all types of marketing authorisations for human and veterinary medicinal products:
EU marketing authorisations:
- Full application
- Generic application
- Hybrid application
- Similar biological application
- Well-established-use application
- Fixed-combination application
- Informed-consent application
- Traditional registration
US marketing authorisations:
- New Drug Application (NDA)
- Abbreviated NDA
- Biologics License Application (BLA)
Which marketing-authorisation process is right for your product?
- National marketing authorisation (EU, US, rest of the world)
- EU, decentralised procedure (DCP)
- EU, mutual recognition procedure (MRP)
- EU, centralised procedure (CP)
Benefit from our expertise from a wide range of successful procedures.
Process and project management
We support you at every stage of the process. You decide at which point you would like our support – in parts or as a full package:
- Strategic consulting
- Scientific advice and meetings with the authorities (including pre-submission meeting or pre-NDA meeting)
- Preparation of the marketing-authorisation dossier
- Compilation of administrative application documents (Module 1)
- eCTD preparation – with external partner
- Submission with the marketing-authorisation authority
- Interaction with the authorities throughout the procedure
- Processing questions from the authorities (assessment reports, deficiency letters, statements)
- Interaction with other involved parties such as toll manufacturers, laboratory service providers