Strategy planning
Defining registration, classification, and gap analysis pathways for EU and non-EU markets.
Regulatory Affairs
Nextrasearch offers Regulatory Affairs as an outsourced service to cover activities falling outside the client's internal expertise or to meet specific, short-term needs.
Service scope
Modular, outsourced regulatory support.
Nextrasearch covers all regulatory requirements, ensuring and monitoring compliance with regulations.It also provides multi-level outsourced support services.
Pharmaceuticals
Support for Marketing Authorizations (MAs) across various procedures.Dossier management.Review of promotional activities.
Regulatory Intelligence & Compliance
Continuous monitoring of regulatory frameworks, international guidelines (MDCG, EMA, ICH, ISO), and the MDR.Updates from Competent Authorities.
Medical Devices
Compliance with EU Regulation 2017/745 (MDR).Support for certification by Notified Bodies.Export support.
Documentation and export support
Preparation of regulatory documentation.Management of documentation for marketing authorization.
Cosmetics and supplements
Preparation of the PIF and management of the CPSR.CPNP management.Management of notifications.
Tell us about your project.
For operational details, scope and support arrangements, contact Nextrasearch directly.