• Regulatory Affairs
  • Medicinal products

Medicinal products

The pharmaceutical quality, efficacy and safety must be guaranteed to obtain a drug marketing authorisation. We know the specific requirements and can lead your projects to success.

Medicinal products for human use

Benefit from our knowledge of more than 100 marketing-authorisation procedures for medicinal products for human use, in which we have supported or acted autonomously on behalf of our clients: primarily national and European processes as well as NDAs for the FDA.

We prepare the CTD for you, in full or as individual components – irrespective of the active ingredient, dosage form or marketing-authorisation procedure. The current regulatory requirements and your individual needs are of course considered.

 

Veterinary medicinal products

Veterinary medicinal products are not the same as medicinal products for human use: the regulatory framework conditions and requirements differ in many aspects!

We can also prepare the complete dossier on these for you – irrespective of the active ingredient, dosage form or marketing-authorisation procedure. Specifically, we produce parts 1 to 4:

  • Part 1: Administrative details and summary of the dossier with the expert reports
  • Part 2: Pharmaceutical quality
  • Part 3: Documentation of safety and residues
  • Part 4: Non-clinical and clinical documentation

 

Core competences

CTD preparation

We can prepare and update the following modules and documents for you:

  • Module 1 with the administrative details according to regional requirements, even if you submit everything yourself
  • Quality overall summary (QOS, CTD Module 2.3) and the corresponding Module 3
  • Non-clinical overview and the tabulated and written summaries (CTD Modules 2.4 and 2.6) and the corresponding Module 4
  • Clinical overview and the tabulated and written summaries (CTD Modules 2.5 and 2.7) and the corresponding Module 5
  • Documentation for traditional registration including preparing traditional documentary evidence for phytopharmaceuticals
Dossier maintenance, life cycle

Maintaining dossiers can be very time consuming as you as the marketing-authorisation holder need to continually keep your dossier up to date. We can do that for you. We carry out the necessary updates, changes and amendments, evaluate them and notify the competent marketing-authorisation authorities.

For life-cycle management we also undertake complete sets of marketing authorisations under portfolio management with all the regulatory, analytical and technical activities required once the marketing authorisation has been issued. Including monitoring deadlines.

Texts

Not only do your texts have to conform with regulatory provisions, they should also represent your drug product in the best possible way. When preparing the summary of product characteristics and package information leaflets and in their life-cycle management, as well as when preparing labelling, we also consider an attractive layout.

Do you wish to include additional patient information? We’d be happy to make some design suggestions.

 

Advertising

Your scientific information material needs to be sound. Does it correspond to the legal regulations in all aspects?

We check your specialist and direct-to-consumer advertising just as we do scientific presentations that you provide for your opinion leaders.

Base dossier for multinational marketing authorisations

We have a lot of experience in this and are happy to advise how you can best create your base dossier for multinational marketing authorisations – in terms of the content as well as strategy. We carry out the relevant adjustments and revisions that will make maintaining cross-regional marketing authorisations significantly easier.

Reformatting

Do you still have a dossier in the NtA format and need to transfer it into CTD format? Or does your dossier need to be revised according to different regional requirements (e.g. US QOS vs EU QOS)? If you wish, we can do that for you.

We can also turn full trial reports into marketing authorisation-compliant – abridged – reports or vice versa for US dossiers. English is not a problem: we offer translation from English as well as into English.

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