• Regulatory Affairs
  • Product development

Product development

Start with a regulatory strategy.

You need to start considering a regulatory strategy early on when developing new active ingredients and products. This is important to avoid conceptional errors and delays in the development process – which saves costs.

Let us support you from the start of preclinical and clinical development: we react flexibly to your requirements and provide you with our extensive experience of regulatory consultation and development projects. If you wish, we can take on the entire project management.

Are you a young biotech company or start-up without a development department? We can offer you our full regulatory, analytical and technical services as well as our network of specialists and partners, all from one source. Working together with you, we ensure your projects are target-driven, cost-effective and a success.

 

 

#productdevelopment

Our services:

Scientific advice

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)
Marketing-authorisation process

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

Dr. Andrea Klüting
Pharmacology

Phone: +49 89 2000203-60
Email:

Bettina Rankl
Quality/CMC

Phone: +49 89 2000203-51
Email:

Contact us. We’re happy to help!

Hotline

Monday - Friday
08:00 - 17:00 o´clock

+49 7272 7767-0