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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.

Understanding exactly what kind of product you are dealing with and a correct classification is essential for defining the regulatory pathway. During this process it is strongly advised to seek scientific consultations with regulatory agencies such as the EMA, FDA, or local authorities during this process to ensure you have an effective strategy and robust scientific evidence.

Conducting a comprehensive GAP analysis is very useful to identify any potential regulatory challenges or gaps in the development process and will help to anticipate key decisions. Based on this, our expert team will help you to develop a clear, actionable regulatory strategy and roadmap that outlines the necessary steps from preclinical development through clinical trials and commercialization.

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

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