PSE provides the following services in the area of drug regulatory affairs:
IFA-related tasks in Germany:
- Customer registration for the German market
- PZN Pre-Allocation
- PZN first publication
- Price adjustments in the IFA article master
- Changes for listed products
- Clarification of other questions relating to the IFA article master
Research in the official article master
We provide you with valuable insights into the competition and market position by analysing the official article master.
Marketing authorisation research
Professional research in the area of drug authorisation and regulatory requirements.
Translations into German or other languages for the national phase
- Translations into German for the “Bescheidmaske” (structured form used for official regulatory decisions during the national approval phase)
- Translations into other languages for the EU authorisation process
Mandatory texts for advertising purposes
PSE creates and reviews mandatory texts for advertising purposes in accordance with current regulatory requirements. Our texts are legally compliant and optimised to ensure compliance with the German Drug Advertising Regulation (HWG) and at the same time present your products effectively.
Product information texts
- SmPC (Summary of Product Characteristics)
- PIL (Patient Information Leaflet)
Mock-ups / artwork
Creation and optimisation of mock-ups and artwork for regulatory submissions.
CPP (WHO Certificate for Pharmaceutical Products)
We support you in applying for and processing the WHO certificate for pharmaceutical products.
Variations
Processing and submission of variations (applications for changes) in the context of drug authorisation.
Dossiers for obtaining marketing authorisation
- Preparation and structuring of dossiers for marketing authorisation
- Submission of authorisation dossiers to the competent authorities