Medicinal Products Marketing Authorisation – Dossier Preparation
During the development of a medicinal product, a large quantity of data is collected that is bundled in complex documentation and evaluated for the marketing authorisation process. This documentation must comply with precisely stipulated norms and convincingly and comprehensibly convey to international and national licensing authorities the quality, efficacy and safety of the medicinal product. The well-being of patients tops the list of priorities throughout the entire process.
The s4s experts apply their strategic expertise with scientific precision to the preparation of persuasive documentation and evaluations for the application process. We expertly advise our clients in all areas of quality, non-clinic and clinic. The acceptance of our work by national and international authorities has been confirmed by our clients through many years of co-operation.
With s4s you can quickly and easily reach your aim of a marketing authorisation – and thus launch a successful market introduction.
s4s prepares all required dossiers and evaluations for chemically defined substances, biotechnologically prepared medicinal products, herbal medicinal products and endogenous substances. This includes all pharmaceutical forms and indications from A to Z, as well as all types of applications.
We base our work on client data and/or conduct extensive literature searches after consulting with the client.
The services of s4s for medicinal product approval and dossier preparation include:
- Literature searches in all relevant databases
- Consulting in our areas of expertise
- Quality dossiers, expert opinions – modules 2.3, 3 CTD (NtA vol. 2B, Human medicinal products)
- Non-clinical dossiers, expert opinions – modules 2.4, 2.6, 4 CTD (NtA vol. 2B, Human medicinal products)
- Clinical dossiers, expert opinions – modules 2.5, 2.7, 5 CTD (NtA vol. 2B, Human medicinal products)
- Traditional use dossiers
- Marketing authorisation dossiers for human medicinal products, modules 1 – 5 CTD (NtA vol. 2B)
- Marketing authorisation dossiers for veterinary medicinal products: administrative documentation and summary of the dossier (part 1), quality documentation (part 2), safety (and residues) documentation (part 3) and efficacy documentation (part 4) (NtA vol. 6B)
- Specialist information (summary of (medicinal) product characteristics, S(m)PC), package inserts
- Environmental risk assessments of medicinal products
- Switch dossiers for medicinal products (prescription → non-prescription)
- Processing of deficiency notices
- Reformatting of NtA to CTD, and CTD to eCTD