Regulatory Affairs

Pharmaceutical Regulatory Affairs

In most companies, the Regulatory Affairs Department is responsible for the following tasks:

  • Ensuring that companies and their products meet all relevant regulations and laws
  • Providing comprehensive support for marketing authorization applications for medicinal, homeopathic and traditional herbal medicinal products
  • Communicating clearly and in a timely manner with all relevant authorities
  • Providing internal advice on regulatory issues and the impacts of all proposed policies and strategies
  • Communication with the Main Association of Austrian Social Security Institutions

How does DREHM Pharma support you with Regulatory Affairs?

Strategy development

DREHM Pharma helps you to choose the best strategy for all approval and variation procedures of your products.

Preparation and review of product information

DREHM Pharma creates and edits technical information for labeling according to your needs in German, English and French.

Support of the marketing authorization process

DREHM Pharma specializes in medicinal, traditional herbal medicinal and homeopathic products, and we will accompany your projects (both human and veterinary) in every phase of an application procedure:

  • Decentralized procedure (DCP)
  • Mutual recognition procedure (MRP)
  • Centralized procedure (CP)
  • National procedures in EU countries
  • Creation of the registration documents (CTD or eCTD / NEES)
  • Editing and processing of deficiency letters

Applications to the Main Association of Austrian Social Security Institutions

  • Preparation and submission of the application
  • Follow-up of the application through inclusion in the reimbursement code
  • Price negotiations for originator products
  • Communication with the Main Association of Austrian Social Security Institutions
**Team Regulatory Affairs** [Meet the team!][2]

Team Regulatory Affairs Meet the team!

Readability tests

DREHM Pharma creates high quality readability tests. These are required for all new authorization procedures for medicines. We perform readability tests in German, but we also offer readability reports in the following languages:

  • German
  • English
  • French

DREHM also offers Bridging Reports and Focus Reports if required.

Lifecycle Management: Regulatory Affairs

DREHM Pharma takes pride in caring for your products throughout their complete lifecycle.

This includes, among other things:

  • Dossier maintenance
  • Variations
  • Renewals (marketing authorization renewals)
  • Communication with National Competent Authorities (NCA)
  • Managing deadlines

Dossiers: creation and reformatting

  • eCTD
  • NEES
  • Reformatting dossiers

DREHM Pharma offers a complete service package for the creation of electronic dossiers, such as eCTD and NEES as well as the reformatting of CTD to eCTD / NEES format. For older products, we are also happy to reformat from NtA to CTD or eCTD format.

Adoption of various important functions

DREHM Pharma provides various legally required features for you, such as:

  • Pharmaceutical manufacturer (DREHM Pharma is GMP certified)
  • Business Manager
  • Qualified Person
  • Information Officer

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We like to share our extensive experience with you!