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?
