Regulatory Affairs

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Regulatory Affairs

We regularly assist small, medium and big European pharm customers with our regulatory affairs services.

With experience in various therapeutic areas (CNS, ophthalmology, oncology, pain, infectious diseases, gynaecology, gastroenterology, cardiology) and with various pharmaceutical forms (oral, parenteral and topical formulations), we have so far licensed a number of innovative and generic medicinal product (including biotech), vaccines, herbal medicinal products, radiopharmaceuticals, blood products and plasma-derived medicinal products as well as medicinal gases.

Approval to conduct a clinical study
Marketing authorization for placing medicinal product on the market
Notification for placing medical device on the market
Ministry of Health approval for food supplements
Cosmetic products registration with CPNP
Placing on the market of general use objects

Clinical studies

Expert assessment of documentation received; drafting and / or adapting Informed consent according to the EU / national requirements; preparation of documentation for investigates; IMPD preparation, review and gap analysis; preparation and submission of CTA to both Ethics committees and Competent authorities; communication with Ethics committees and Competent authorities; submission of amendments and addition to the study documentation up to the Clinical Study Report

Medicinal products licensing

Compilation of application dossiers (Module I-Module V); Non-clinical (Module 2.4) and Clinical (Module 2.5) Expert Report preparation; Product information generation in QRD format in English and translations to local languages (SI / HR / CS / B&H / MN / MK); MAA filling in client-selected format (NTA / CTD / NeeS / eCTD); communication with regulatory authorities; filling of variations throughout the medicine lifecycle; Preparation, marketing materials review and harmonization with approved medicinal product documents

Medical devices / Food Supplements / Cosmetic Products / General Use Objects

Conducting clinical trials on a medical device; registration of the client in the Register of medical device wholesalers; registration of medical devices in the Register; translations of Instructions for use into national languages; change of Class of risk; drafting and reporting of Safety notification and / or Safety Corrective Action; communication with regulatory authorities
Registration of a legal entity as the Food business operator; verification of eligibility of ingredients in the food supplement; drafting a declaration in the national language; applying to the Ministry of Health and assisting the client in obtaining approval; marketing materials revision
Classification of cosmetic product (including borderline), Cosmetic Product Safety Report preparation, facilitation of product testing in an EU OMCL, Responsible person and/or distributor registration in CPNP, product registration in CPNP, declaration translation into national languages