Regulatory Affairs Services
Regulatory Affairs Services
Katja Delić, MSc
Head of regulatory affairs department
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 where we operate.
We provide our clients with services:
- of high quality
- in compliance with regulatory requirements
- delivered on time
We provide service for all:
- medicinal products (MPs, DCP, MRP, NP),
- veterinary medicinal products (VMPs, DCP, MRP, NP),
- medical devices, food supplements, cosmetics, and biocides.
Submission of Marketing Authorisation Applications
Our Regulatory Affairs professionals prepare submissions for:
- Innovative and generic medicinal products (including biotech)
- OTC
- Vaccines
- Herbal and homeopathic medicinal products
- Radiopharmaceuticals
- Blood products and plasma-derived medicinal products
- Veterinary medicinal products (VMPs)
Pre-authorization support
Our Regulatory Affairs professionals offer expert advice on submission strategy.
Expert Reports
Our Regulatory Affairs professionals offer preparation of quality (Module 3), non-clinical (Module 2.4) and clinical (Module 2.5) overviews and summaries.
Our Regulatory Affairs professionals offer preparation of safety (as well the ERA report) and residues (Part III) and efficacy (Part IV) expert reports, summaries, and statements for VMPs.
eCTD format
Our Regulatory Affairs professionals offer preparation of marketing authorization application dossiers in:
- eCTD and Nees format,
- conversion from exsisting paper and/or electronic CTD or NtA to eCTD or NeeS format,
- eCTD publishing.
Post-approval and submission support
Our Regulatory Affairs professionals offer post-approval and submission support:
- preparation, submission, and management of various applications, renewals, and notifications
- update and upgrade of documentation
- translation, preparation, and coordination of information about the product (SmPC, PIL, labelling) in accordance with Slovenian, Croatian, B&H, Serbian, and Macedonian medicinal product legislation
- marketing materials review, harmonization with approved medicinal products documents
- communication with authorities (new requirements/answers to deficiency/ clarifications/permissions)
- preparation of packaging materials (mock-ups/artworks) and proofreading
Consultancy
Our Regulatory Affairs professionals have over 10 years of experience and are willing to provide you with the regulatory advice that you need.
