Medicinal Products

We support marketing authorisation projects for human medicines under national and European law from the development phase and throughout the entire lifecycle of the medicinal product.

This includes:
  • National procedures in all EU member states and in Switzerland
  • EU procedures
    • Centralized Procedures (CP)
    • Decentralized Procedures (DCP)
    • Mutual Recognition Procedures (MRP)
    • Repeat Use Procedures

Our services include:

Assistance in the context of marketing authorisation procedures
  • Selection of a suitable licensing strategy with regard to the type of procedure, the type of application and, if applicable, RMS / CMS
  • Assessment of existing documents on suitability for approval
  • Preparation and submission of applications for scientific and procedural advice
  • Dossier preparation and submission
  • Procedure management and correspondence with regulatory authorities
  • Response to deficiency letters
  • Conduction of the national phase after completion of the procedure

Assistance in maintenance (lifecycle management)
  • Preparation and submission of variations, national change notifications, renewals
  • Proof and revision of product information texts (summary of product characteristics, package leaflet and labelling)
  • Submission of PSURs

CMC dossiers
  • Deficiency analysis of registration dossiers
  • Check for consistency between the approval dossier and manufacturing documents (regulatory compliance) as well as updating of the approval documentation
  • Preparation of validation plans for production
  • Risk analysis for elemental impurities
  • Preparation of the chemical pharmaceutical documentation (Module 3)
  • Preparation of expert opinions for the evaluation of the chemical-pharmaceutical quality of medicinal products (Quality Overall Summary, Module 2.3)

Clinical dossiers
  • Deficiency analysis in registration dossiers
  • Preparation of clinical documentation:
    • Clinical Summary (Module 2.7)
    • Clinical Study Reports (Module 5)
  • Preparation of expert opinions to evaluate the efficacy and safety of medicinal products (Clinical Overview, Module 2.5)

Additional services
  • eCTD service including creation of baseline eCTDs
  • Reformatting of marketing authorisation dossiers from
    • NtA in CTD format or
    • CTD in NeeS and eCTD structures
  • Red List, Yellow List, Fachinfo-Service, IFA registration
  • Support in the creation of educational material
  • Applying for WHO Certificates for Pharmaceuticals (CPP)
  • Application for wholesale license according to § 52a AMG, manufacturer's license, import license
  • Supervision of readability tests
  • Preparation of compulsory texts for promotional materials
  • Customer training