Benson MedReg AB

Benson MedReg offers the following services:

Preparation of SPCs (Summary of Product Characteristics), labelling and PILs (Patient Information Leaflets)

Handling of product texts (FASS catalogue, SPC, PIL) in

High quality translations of English/Swedish pharmaceutical and medical documents

Medical writing, review and editing, e.g. manuscripts for publication

Readability testing of package inserts. The interviews are carried out by psychologist, and graphic design of the package insert can be offered. The final report is written in English.

Adapting legislation into lay language, e.g. control program for OTC retailers. An example is presented under tab Health Care Projects.

Preparation of SOPs (Standard Operating Procedures), e.g. handling of complaints and recalls.

Compilation and summarising of product complaints

Regulatory advice, including liaison with regulatory bodies

Review of regulatory documentation

Applications for clinical studies to regulatory bodies and ethical review boards

For our specialities please refer to tab Our specialities.

Regulatory Affairs Services provided: