Your professional team for
Regulatory Affairs

Efficient – Pragmatic – Helpful

We have everything important on the radar

Whether for a project or as your external RA department. We manage your admissions. And more. We love and live Regulatory Affairs.

With the experience of hundreds of different approvals with a wide variety of challenges, our team of complementary experts, and good contacts to all relevant authorities, your Regulatory Affairs tasks are in the best hands with us.

We provide you with tailor-made and reliable support

  1. For individual approval projects
  2. For a limited period of time (e. g. as a maternity leave replacement)
  3. Permanent as your external RA department

You can also rely on our Quality Check at any time thanks to the 4-eye principle. And thanks to back-ups, your admission projects are always “work in progress” with us.

Our key areas

Our team of experts handles all types of marketing authorisation procedures for you, whether DCP, MRP/RUP, or national procedures and also supports you with the life-cycle, be it variations, renewals, or transfer. For first-time submissions, we can also take over the MAH function for you if required. Basic and further information on marketing authorisation procedures can be found in particular on the website of the Federal Office: Marketing-authorisation & Life-Cycle – BASG

You are not sure which path to authorisation is the right for you? You explain to us what your objectives are, and we help you choose the optimal strategy for approvals and variations of your products.

You have new plans for pharmaceuticals based on old files? Or do you need a careful examination of the status of approvals and their potentials, for example in the context of a due diligence? We analyse the status of approvals for you in terms of timeliness and marketability.

How does your patient information leaflet meet accessibility requirements? We train your team, or directly support you with the implementation. Basic information on the subject can be found here: Accessible patient information leaflet – BASG

You need a person who, in accordance with § 56 AMG, has the necessary expertise and experience to perform the role of an Information Officer on a short-term or permanent basis? We are here for you. Here you can find the legal basis for the Information Officer: § 56 AMG (Arzneimittelgesetz), Informationsbeauftragter – JUSLINE Österreich

Our special areas

Our team of experts has experience with all types of approvals and accompanies your projects at all stages. Over the years, three areas have emerged in which we have been able to develop special expertise thanks to personal interests and numerous completed projects:

Herbal medicines are one of our specialities. We evaluate the type of application for your composition (bibliographic application/WEU or Traditional Herbal Medicine/THMP) and, if necessary, research the traditional documents. Special features in product information texts or module 3 and CMC are not a challenge for us.

The quality part of dossiers containing data on CMC (Chemistry, Manufacturing and Controls) requires specific technical know-how, which we are happy to provide. Whether for necessary file updates, the evaluation of planned changes or a GAP analysis.

We are also happy to assist you outside of pharmaceuticals: We check the formulation of your food supplement idea, evaluate the ingredients, support you in formulating possible health claims or support you on the way to the Marketability report.

Long discussions, unproductive meetings and phone calls are not our thing. We offer you flexible solutions, find an efficient way of working together, complete our tasks without detours and are always there for you when help is needed.

  • Pragmatic
  • Reliable
  • Efficient
  • Helpful
  • Solution-oriented
  • Uncomplicated
  • Flexible

You learn with us

“Sharing the experience” is the motto of DREHM. And you, as our customer, benefit in particular: be it through the ongoing exchange with our specialists, by answering your technical questions, or by providing tailor-made training for you and your team.