Other Services

Market Access
Other Services
Scientific Service
Medical Devices\Foods
Proxy Service

Due diligence

Due diligence: for a new product: examination of the current legal framework for a rational development of the product; for pre-existing products:
examination of all documentation concerning the product and report of any possible problems, in order to be sure that there will not be additional costs resulting from lack of documentation or possible future regulatory issues.

Readability user test

Support for the preparation of the section 1.3.4 of the registration dossier for new marketing authorization (national or European).
GB Pharma realizes the Readability User Test in all its stages: protocol, preparation of the questionnaire and the documentation for the interview, recruitment of personnel to be interviews, instructions to the psychologist for the interview, preparation and printing of the mock up for the Readability User Test, statistical analysis of the results of the interview, final report in Italian or in English.

Regulatory support in Extra-EU Countries

  • Support for the registration and maintenance of medicinal products in Extra-EU Countries (e.g. Middle East, North-Central and South America, Asia, Africa, etc.), in accordance to local procedures and requirements.
  • Development of the registration dossier and support during all registration process phases, also with co-operation with local agents.