Partners in Regulatory Affairs

As a specialised service provider, our concept is to collaborate with other regulatory affairs service providers, which can contribute complementary services or additional resources.

Translation Services

Within the Labelling Service we successfully collaborate, since more than 10 years, with a dedicated medical translation provider:

• Founded in 1998
• Market leader in translations for the medical and pharmaceutical industry
• Over 60 permanent employees and a worldwide network of external technical translators and reviewers

Adjacent Regulatory Services

For adjacent regulatory services, we work in a close partnership with a Regulatory Service Provider, a well-established Partner of the Pharmaceutical Industry for development, regulatory and market access:

• Established since 1994
• Represented in >90 countries via a network of partners & network members
• Providing services (besides others) in the following areas:
  • Drug Development (all phases), Scientific Advice
  • Regulatory Affairs (Strategy and implementation of submissions), covering all types of registration procedures, new MAAs or product maintenance submissions, based on CTD / eCTD
  • Pharmacovigilance
  • Capable to address local questions and provide local authority contacts using local resources

Artwork Solution Services

For adjacent artwork solution services, we work in a close partnership with a well-established Artwork Solution Provider:

• Founded in 2007
• Located near Freiburg
• Offering the advantage of holistic solution packages or to make the most of individual services for optimising your value-added chain:
  • Creating and processing artwork
  • Coordinating artwork with printing houses
  • Managing artwork in line with approval services and authorities
  • Lean management in the artwork lifecycle: Workflow integration and process optimisation
  • Project management along the entire value-added chain