Regulatory Affairs

Pharmaceutical department aimimg to ensure public health protection by ensuring the efficacy and safety of medicines, medical devices, cosmetics, biocides and food supplements.

We provide a complete regulatory service with the highest quality standards and practical expertise, from the introducing of a drug on the market, to AIM terms variations, so that the life-cycle is always covered and the medicine marketed accordance with the laws and regulations in force.

 

  • Registration dossiers

- National, Mutual Recognition and Decentralized Procedures

- Counseling and outlining strategies to obtain MA

- Preparation of documentation in CTD format, eCTD, NeeS. In Portuguese, French or English.

- Organization of texts and opinions to support the request

- Expert reports

- Provision of all Bibliography for the processes

 

  • Readability tests of the package leaflet

- We present the final reports and corresponding charts, according to European standards.

- We have the respective SOPs for these readability tests.

 

  • Others

- Monitoring of the whole evaluation process in the regulatory authorities:

- Answers to all questions raised during the evaluation process

- Resources, Opinions and petitions.

- Trademark registration

- Studies of BD / BE

- Gap-analysis

 

  • Licensing

We prepare and handle all the necessary documentation for the licensing process of companies operating in the areas of human medicines, veterinary, medical devices and health products.

Preparation of Manuals of Procedures and Standard Operating Procedures.

Entities associated with the manufacture, importation, wholesale distribution, dispensing to the public of medicines and health products.

- Pharmacies

- Mobile Pharmacy Stations

- MNSRM Sales Locations

- Wholesale Distributors

- Public and private pharmaceutical services

- Manufacturers

- Medical Clinics and Medical Offices