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Consulting

PRSG offers a comprehensive portfolio of regulatory services and consulting, comprising best practices and solutions for several categories.

  • Medicinal Products

  • Medical Devices

  • Food Supplements and Food for special medical purposes (FSMPs)

  • Cosmetics

MEDICINAL PRODUCTS

  • Preparation and attendance at meetings with authorities

(pre-submission meetings, scientific advice)

  • Quality management

  • Pharmacovigilance assistance

  • Non-Clinical & Clinical Studies

  • Application for SME status

  • Application for Scientific Advice related to Quality, Non-Clinic or Clinic

  • Strategic and regulatory advice for national/international Issues

  • Choice of appropriate application procedures

  • Evaluation of regulatory or CMC documentation

  • Compilation of a complete MA dossier

  • Dossier creation (Dossier creation)

  • Regulatory and commercial compliance  (Maintenance) 

    - Life Cycle Management (Variations, Renewal procedures,...)

    - Product Quality Reviews

MEDICAL DEVICES

  • Strategic and regulatory advice for importers and distributors of medical devices in Austria

  • Compliance with the requirements of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)

  • Support in the fulfillment of general obligations of importers (Article 13 MDR/IVDR) distributors (Article 14 MDR/IVDR), including documentation for the quality management system

  • Support with actor and product registration in EUDAMED and Austrian Registry of medical devices

  • Regulatory guidance on labeling compliance of packaging materials and user manuals for the Austrian market

  • Review of promotional material

  • Materiovigilance assistance

  • Marketing of medical devices in Switzerland

FOOD SUPPLEMENTS & FOOD FOR SPECIAL MEDICAL PURPOSES (FSMPs)

  • Strategic and regulatory advice for legally compliant marketing of food supplements and FSMPs in Europe

  • Registration of food supplements in Europe

  • Regulatory guidance on labeling compliance of packaging material and package inserts

  • Review of health claims, legal admissibility, and maximum permissible quantity of ingredients

  • Review of promotional material

  • Support in the development, preparation of dossiers, and registration for FSMPs

COSMETICS

  • Strategic and regulatory advice for legally compliant marketing of cosmetics in Austria

  • Regulatory guidance on labeling compliance of packaging material and user manuals

  • Review of promotional material