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    SciencePharma offers multidisciplinary services covering all aspects of regulatory affairs, including pre-authorisation stage of a medicinal product (human/veterinary). We also have all the conditions to support your company in the field of regulations regarding medical devices, cosmetics and supplements. We also assist in placing medical devices, dietary supplements or cosmetics on the market.

    Scope of pre-authorisation services:

    • Regulatory strategy preparation indicating the optimal registration path, registration category, costs and the chances of the project success
    • Assessment of documentation readiness for the registration procedure – so-called ‘dossier Gap analysis’
    • Planning, organization and active participation in Scientific Advice and pre-submission meetings
    • Product Information management covering both: Readability test & Bridging report, Product Information Preparation & Verification (including mock-ups) & Translation, and Educational materials verification,
    • Preparation of registration dossier (modules 1-5) for the national and European procedures in CTD/eCTD/NeeS format encompassing starting from Application Form Preparation, through Quality Overall Summary (QOS) & Module 3 preparation ending with the preparation of non-clinical & clinical part of dossier, and much more.

    How can we help You?

      Please be advised that the administrator of personal data entered in the above form is SciencePharma Sp. z o.o. with its registered office in Warsaw, Chełmska 30/34. These data are processed in order to receive incoming correspondence and respond to it. Providing personal data is voluntary, but necessary to send the form. Each person has the right to access their data and correct it.

      You can read the details on the protection of personal data here.