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General tasks within Regulatory Affairs
A-consult provides professional regulatory assistance to companies in the development, production, and marketing of pharmaceuticals.
We have great experience within medicinal products including OTC products, Herbal medicines and Homeopathic remedies, ethicals and generics.
We provide expertise in:
- National procedure (NP) applications
- Mutual recognition (MRP) and decentral procedure (DCP) applications
- Centralised procedure (CP) applications
- Strategic advice on the regulatory and administrative procedures of the Scandinavian authorities
- Applications for Type I and Type II variations and renewals
- Contact and negotiations with the Scandinavian Medicines Agencies
- Support in relation to application for scientific advice incl. preparation for meetings
- Compile and submit Marketing Authorisation Application (MAA)
- e-CTD
- Conversion of dossiers to CTD format
- Evaluation of documentation, e.g. module 1, 2 and 3
- Veterinary product registrations and maintenance
- Registration of generic products and bibliographic applications
- Extension applications
- Update documents, e.g. SPCs, PILs and labelling according to the local legislation
- Translation of local language documents, e.g. SPCs, PILs and labelling into Scandinavian languages
- Preparation of safety update reports (PSUR) and module 2 overview and summary reports incl. Expert statements
- Review of marketing materials
- Clinical trial applications
- Compilation, review and update of drug master files (DMF)
- GDP issues incl. perform quality audits and Danish §39 application
- Provide Qualified personnel
- Substitute for Regulatory Affairs manager or employee
- Support from our offices or at your site
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a-consult.dk