As an added-value service which complements the R&D projects developed for third-parties, Reig Jofre has a technical team with extensive experience in the regulatory field on a worldwide level, and especially in Europe and USA. The team offers:
- Preparation of registration dossiers for presentation in EU and non-EU countries in SENs and e-CTD formats using specific software.
- Experience in registration processes at European level, via domestic mutual recognition or decentralized procedures. Regulatory support, from the presentation of the registration to the approval of the drug by answering the allegations requested by the various regulatory authorities, including post-approval regulatory work, such as presenting variations or renewals.
- Possibility to design the development of third-parties products according to ICH Q8 standards and prepare the presentation of the application for the commercialization authorization.