Regulatory
Technical Services
Bringing a new product to market, whether it is in medicines (new chemical entities, biologics, ATMPs), medical device (MD, MDSW, IVD), biotech, nutraceuticals…etc. is a complex and highly regulated process in which having a regulatory strategy is crucial to ensure success, minimizing delays and reducing risks. Our expert regulatory consulting services are designed to guide you through every step, with tailored regulatory strategy which guarantee that your product meets all necessary requirements.
Our expert team will handle the preparation and submission of your corresponding regulatory dossier, ensuring that all required documentation is complete, accurate, and aligned with the relevant regulatory standards. We support you throughout the approval process, responding to any questions or requests from the authorities.
- Product qualification and classification.
- Preliminary advice on the regulatory framework of the products.
- Scientific advice and consultation with regulatory agencies (National Competent Authorities, EMA, FDA, Local Authorities).
- GAP analysis and regulatory strategy.
- Regulatory Roadmap: definition of key regulatory milestones in the preclinical and clinical phases for project development until commercialization.
- Advice on Preclinical, Clinical Development.
- Preparation and submission of the corresponding dossier/technical file, support and follow-up of queries or requirements during the authorization process.
- Support in post-marketing activities