Regulatory affairs

Our Regulatory Affairs Professionals offer a full range of regulatory procedure services.

Regulatory affairs services

Our Regulatory Affairs Professionals with extensive experience across a full range of regulatory procedures are highly skilled in interfacing with regulatory authorities in all countries of operation

We provide our clients with services:

  • Of high quality
  • In compliance with regulatory requirements
  • On time delivery

We provide regulatory service and support for:

  • Medicinal products (CP, DCP, MRP, NP)
  • Veterinary medicinal products (CP, DCP, MRP, NP)
  • Medical devices
  • Food supplements
  • Cosmetics
  • Biocides
  • General goods

Our Regulatory Affairs Professionals offer expert advice on submission strategy.

  • Innovative and generic medicinal products (Rx/OTC)
  • Vaccines
  • Herbal and homeopathic medicinal products
  • Radiopharmaceuticals
  • Blood products and plasma-derived medicinal products

Preparation of reports, overviews and summaries:

  • Quality (Module 2.3)
  • Non-clinical (Module 2.4)
  • Clinical (Module 2.5)
  • ERA
  • Safety, residues and efficiency reports
  • eCTD and Nees format
  • Conversion from existing paper and/or electronic CTD or NtA to eCTD or NeeS format
  • Local Marketing Authorization Holder/Local Representative role
  • Preparation, submission, and management of various applications, renewals and notifications
  • Documentation upgrade
  • Translation and preparation of Product Information in accordance with Slovenian, Croatian, Bosnian-Herzegovinian, Serbian, North Macedonian and Montenegrin legislation
  • Marketing materials review, harmonization with approved product documents
  • Interfacing and communication with regulatory authorities
  • Support with mock-up preparation and proofreading
  • Readability user testing
  • Pricing and Reimbursement

Our Regulatory Affairs Professionals have over 10 years of experience and are willing to provide clients with the regulatory advice.

Do you want to work with us?