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Dokument s perem
“All-in-one” regulatory services
Quality assurance -  QA / QC
  • Quality assurance

  • Communication with authorities

  • SOPs and other set of documents

  • Qualified person

  • Education


Product Classification
  • For distributor/manufacturer and notification of the products in the EU

  • Preparation, review and updating of technical documentation


Regulatory documentation
  • Compilation of regulatory dossiers

  • e-CTD publication

    • Compilation and evaluation of the partner file

    • Completeness and quality check – pre-submission

    • Creating eCTD files and formats

    • Support in creating Module 1 for all procedures according to national/EU requirements

  • File of forms/documents for key regulatory processes



Market Access
  • Market access strategies and plans

  • Price and reimbursement strategies

  • Pharmacoeconomic and research outcome

  • Health technology assessment

    • Medicinal products

    • Medical devices

    • Screening programs


PASS Management
  • Definition of scientific format of protocols, abstracts and final study report for non-interventional PASS

  • Identification of the Requirements and Key elements for PASS

  • Creating Guidance on Effectiveness of Risk Minimization

  • Establishing monitoring system – GVP (Good Pharmacovigilance Practice)

  • E-register of non-interventional PASS maintained by the Agency

  • Preparation and publication of Final Study Report

  • Classification of borderline products according to the EU regulation 1223/2009/EC Notification of medical devices and submission of documents to local authorities

  • Classification of medical devices in accordance with European regulations – CE mark

  • Notification

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