Services

Regulatory services

We perform regulatory services for human and veterinary medicinal products with a team of highly qualified experts, specialised in the field of regulatory affairs.

Join numerous international pharmaceutical companies that trust us for several years.

In the field of registration of medicinal products, we perform all activities necessary for the placement of the medicinal products on the market as well as activities necessary for the maintenance of marketing authorisations:

  • National procedures (NP), mutual recognition procedures (MRP) and decentralised procedures (DCP) – obtaining, extension, renewal, variation of marketing authorisation and notification.
    The scope of the services we provide:
    • Support prior to the issuance of the marketing authorisation, preparation and submission of applications, supplementation of the documentation upon request of the competent authority, procedural advices, contact with the competent authority,
    • preparation and review of translations of the product information (SmPC, PIL, labelling) in accordance with the QRD and national requirements.
  • Centralised procedures (CP)
    The scope of the services we provide:
    • preparation and review of translations of the product information (SmPC, PIL, labelling) in accordance with the QRD and national requirements;
    • advices on local particularities;
    • notification and preparation of blue-box applications.

Value-added services that we provide to our partners include professional review of marketing materials and preparation of applications for different labelling of medicinal products, for an individual deviation from the terms of marketing authorisation (OOS) and exemptions from the application of the sunset clause.

In addition, we also offer regulatory services for medical devices and food supplements, such as notification at the competent authority and translation and peer review/correction of texts.