At Qualipharma, our Regulatory Affairs service supports your product from conception to commercialization. We work closely with R&D+I teams, API manufacturers and Marketing Authorization Holders to ensure regulatory compliance at every stage, whether for pharmaceuticals, medical devices, food supplements, cosmetics, personal care products or biocides.
Comprehensive Regulatory Affairs support for pharmaceutical products in both national and international markets.
Pre-Submission Registration Operations Each project receives personalized support to ensure a commercially viable Marketing Authorization (MA) and its subsequent maintenance in compliance with current legislation.
We develop registration strategies, risk analysis and scientific advices to ensure your products – whether human or veterinary medicines – meet regulatory requirements from the outset.
Discussing regulatory strategy design – including legal basis, procedure type, and target countries – lets us to anticipate potential challenges.
Our support includes:
From Submission to Approval Before launching a product in the client’s target territories, Qualipharma provides support in managing local regulatory requirements and fulfilling commitments made to authorities during the dossier evaluation.
Post-Marketing Obtaining Marketing Authorization is just the beginning of a product’s lifecycle. The MA holder is expected to keep it updated through post-marketing activities, including five-year renewals, regulatory commitments, and quality and safety variations.
We manage communication with agencies in cases of temporary suspensions or MA withdrawals.
Promotional Materials Review Maintaining Marketing Authorization may involve reviewing and preparing promotional materials.
Specialized Training Certify your expertise in Regulatory Affairs with our catalog of online and in-person tailored courses. Discover e-learning by Qualipharma.
Our specialized team ensures full compliance with applicable regulations from classification to market launch.
Classification Strategy We develop precise classification strategies for both the EU and the US markets, considering:
Technical Documentation We handle the creation of technical documentation, compiling all necessary information to demonstrate compliance with regulatory and safety requirements under Regulation (EU) 2017/745 (MDR) and FDA 21 CFR 820.
Post-Marketing Qualipharma helps prevent risks, manage clinical data, and ensure compliance throughout the lifecycle of a medical device.
Specialized Training Certify your expertise in Medical Devices with our catalog of online and in-person tailored courses. Discover e-learning by Qualipharma.
We offer customized solutions to ensure regulatory compliance for dietary supplements, cosmetics, and personal care products.
Food supplements We manage market notification, composition review, and labeling compliance according to EFSA and AESAN regulations.
Cosmetics We handle CPNP notification, Product Information File (PIF) creation, and ensure full compliance with European cosmetic regulations.
Personal Care We ensure prior health authorization, manufacturing and importation approvals, and safety assessments through technical and toxicological reports.
Biocides We manage European and national biocide authorizations ensuring compliance with ECHA regulations.
Specific Management System
We use IUCLID documentation for dossier evaluation management, ensuring compliance with applicable biocide regulations.
Biocide Labeling
We guarantee compliance with EU and national biocide labeling regulations.
Specialized Training Certify your expertise in Regulatory Affairs for other sectors with our catalog of online and in-person tailored courses. Discover e-learning by Qualipharma.
Tell us about your needs, and our team will find the best solution for your project.
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