I provide regulatory affairs consultant services related to products for humans and for farmed fish. My assistance might vary from small to bigger tasks like for example:

• proofreadings, updating of product information, translations
• handling variations and renewals
• strategy advising using generic/hybrid/full-mixed/bibliographic MAA
• classification of products: medicines, feed additives, biocides, cosmetics
• preparation of dossiers/responses for regulatory authorities
• generating bibliographic clinical- and nonclinical documentation
• liaison with agencies on your behalf
• variation classification and choosing of single, grouped or work sharing
• advising on DCP, MRP, national procedure
• transfer of MAs
• bridging to user tested package leaflet
• regulations on invented name and design of packaging
• marketing regulations
• applications for clinical field trials for fish
• support and coordination of scientific advice meetings with NoMA
• transformation of complex scientific documents into popular literature