Consulting and regulatory
Technical regulatory support
Consulting and regulatory
In Methodex, we offer a consultancy and legal support service of different regulatory and registration aspects of products in health field (medication, sanitary products, alimentary complements and cosmetic products).
Our expert team works with the compliance of the normative established by European Union for the commercialization authorization of cosmetic and medical use products in humans, offering a complete support in legal and regulatory aspects from a pre-clinic stage to post-commercialization stage.
The consultancy in regulatory aspects let to define the briefest way and the temporal needed setting to put your product or group of products on the market, guiding you on the different stages of the process and with the deal with the pertinent authorities.
In Methodex, we have a wide experience in:
- Preparation of all the documentation for Registration Record (complete applications, variations, line extension, renovations, etc.) in a Common Technical Document (CTD format for national procedures, of mutual recognition, centralized or decentralized. We are in charge of the preparation, the revision and the submission of the commercialization authorization applications.
- Redaction of the pre-clinic and clinic rapports by an expert, quality rapports and security actualizations.
- Redaction and adaptation of the labeling, technical datasheet and leaflets.
- Evaluation of the registry record
- Juridical advising
- Prices and refund Politic definition
- Obtaining of licenses for fabrication and commercialization
- Registry of alimentary complement
