Regulatory affairs for medicines for human use
Regulatory submissions and life cycle maintenance, post-approval, promotional review and approval.
- GDP consultancy - local storage and distribution licence
- Determination of regulatory and legal status
- Determination of regulatory strategy for planning, manufacturing, preclinical and clinical development
- Document preparation including marketing authorization applications for medicinal products (mod. 1-3)
- Submission and management through to approval of marketing authorization applications via the EU, Mutual Recognition, Decentralised or National Procedures
- Follow-up of applications including support for responding to deficiency letters from local authorities
- Maintenance of existing marketing authorizations (variations/renewals/readability testing/Sunset Clause)
- Translation services
- Support for general Storage and Distribution Licenses for medicinal products / medical devices
- Pharmacovigilance support (acting as Local contact Person for PharmacoVigilance - LPPV)
- Critical review of advertising and promotional materials (local responsible person - local Information Manager)
- Liaison with national competent regulatory authorities
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