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LIFE SCIENCES

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In recent years, the pharmaceutical industry market, namely the OTCs, food supplements and medical devices, has gone through a complete approach change, mainly due to the market opening and growth (specially the one integrated in the major retailers). Derived from this change, new launches became linked with heavy investments in communication, far more dynamic and using several of the same techniques used for mass market products

In addition, new challenges arose from the fact that the existing transparency disclosure system in place for medicines was transcribed for the medical devices in early 2017, with all the profound changes that came along with it for such market, together with the complete change in the rules for the industry to carry out education and scientific events on NHS facilities. 

Regarding medicines, our team advise on several areas of the law, that go beyond the technical aspects, working closely together and in partnership with the Client's regulatory departments, in relation, among others, to:

  • Agreements with public entities and patient associations
  • Compliance with industry and ethical codes of conduct
  • Standard Operational Procedures (SOP's) Medicines - EFPIA HCP Code (Apifarma in Portugal)
  • Clinical Trials (in particular issues regarding data protection/GDRP compliance and insurances)
  • Sponsorships and Grants to HCPs (Transparency disclosures compliance)
  • Pharmacovigilance

Our vast experience, also in the mass market, allows us to provide the best services to our Clients, in all matters related to:

  • Launch of OTCs, food supplements and medical devices
  • Product labelling
  • Advertising claims and support
  • Prize promotions (POS or digital/social media)
  • Medical Devices- MedTech Europe Code of Ethical Business Practice (Apormed in Portugal)
  • In Vitro Medical Devices - MedTech Europe Code of Ethical Business Practice (Apifarma in Portugal)