Medicinal Products
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)
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