“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

 

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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

 

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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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