Regulatory
Affairs

The field of RA encompasses all the work necessary to manage products’ registrations and to receive and maintain marketing authorization.
Choose PQE Group’s comprehensive support and broad strategic knowledge to launch products without delays and keep them on different worldwide markets.

Discover our solutions

Pharmaceuticals

Compile all the required informations for the amendment of the CTD dossier and stay ready for regulatory inspections targeting pharmacovigilance.

Medical Devices

Registrate and certificate MD and IVD products while collecting all intelligence on clinical evaluation, post-market surveillance and device vigilance.

Leverage regulatory strategy

To successfully comply with regulatory requirements and avoid penalties, rejects and delays, Life Science businesses need to be aware of the challenges posed by different laws operating in different market regions. Don’t risk losing quality and trust: choose the right training, guidance and support.

  • Manage products’ approval and registration
  • Speed up products’ launch
  • Reach different countries and assure global coverage
  • Keep products on the market consistently
  • Coach R&D to collect the right data from the first stages
  • Improve and standardize regulatory processes

Regulatory Solutions: a focus

A roadmap to EU MDR

PQE Group offers a specific regulatory support to any MD businesses looking to launch on the European market, needing guidance with CE Markings or wanting to ensure business continuity and renewal.
Book your first assessment with our team of experts and set up a time-tested strategic action plan to effectively and competitively manage regulatory compliance.

In-country Caretaker Service

To export products in Japan and handle Japanese regulatory procedures smoothly, foreign Life Sciences businesses are required to appoint an ICC (in-country caretaker) that will perform tasks concerning registration, review, GMP, translation and so on.
Thanks to our local experts and the broad presence of PQE locations across relevant market regions such as Japan, we can support you globally thinking locally.

Cannabis related regulatory standards

Many countries have already legalized the therapeutic use of Cannabis’ non-psychoactive varieties and many others are ready to follow this trend.
Read our article about the laws and regulations that apply to the medical cannabis market and be ready to follow these standards choosing PQE Group as your valuable and expert partner.

Why PQE?

To easily navigate the increasingly complex regulatory market and help our clients comply and sell their products in EU, US and Canada, LATAM, MENA, CIS, Africa and APAC, PQE Group relies on highly flexible and close multicultural teams of consultants expert in the laws and regulations operating in various countries.

Full Service Portfolio

Pharma Regulatory Affairs Full Service Portfolio

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We will be more than happy to help you find the most suitable solution for your business.