In general: Preliminary pre-market review/registration strategy/depending on the product type
Medical equipment
Coordination of document preparation in cooperation with manufacturers, project groups, specialists, suppliers, distributors and the authorities.
- Information retrieval in relation to a toxicological assessment/biological evaluation/risk assessment/clinical evaluation
- Writing reports in cooperation with the manufacturer in relation to the relevant standards
- Preparation of quality procedures for medical equipment, including procedures for market surveillance and reporting of critical incidents
- Evaluation of labelling/user’s guide/promotion material
- Preparation of registration files and cooperation with the authorities during the registration process
- Postmarketing surveillance og legislation, guidelines, standards etc.
Food supplements
- Information retrieval in relation to toxic assessment/effects of the product, incl. report
- Evaluation of labelling/package insert/promotion material
- Notification of food supplement and cooperation with the authority
Herbal remedies, traditional herbal remedies
- Information retrieval in relation to toxic assessment/effects of the product, incl. report
- Evaluation of labelling/package insert/promotion material
- Working out registration files in cooperation with the manufacturer, project groups and specialists, suppliers, distributors, authorities and cooperation with the authorities during the registration process
Cosmetics
- Information retrieval in relation to toxic assessment and effects of the product, incl. report
Evaluation of labelling/package insert/promotion material
- Document preparation in cooperation with manufacturers, project groups, specialists, suppliers, distributors and the authorities.
Offers in connection with specific registration assignments
I will provide a list of all the matters we have discussed and will on the basis thereof relate to the following questions:
- Is the product recordable? Preliminary pre-market review/registration strategy/depending on the product type.
- Under which legislation(s)?
- If yes, how can it be promoted on the chosen markets?
- An assessment of the existing documentation/quality control.
- Is there a need for further documentation/quality procedures?
- A dialogue and sparring with other experts/authorities.
- A plan for the preparation of documentation and registration.
- Quotation for the preparation of registration files and the coordination of the preparation of the documentation.
