Full regulatory support: from initial guidance to dossier preparation/build-up, MA submission and post-MA dossier management.
Guarantees the real-world vigilance of medicinal products, cosmetics, supplements, medical devices and cannabis-based products.
From isolated tasks to assembling the pharmacovigilance system, we guarantee the performance of these services while meeting the growing requirements of the industry.
Writing of scientific documents to support medical, clinical & scientific projects. A dedicated and highly qualified team working with robust quality check procedures to ensure efficient medical writing.
Quality Assurance services oriented for MAH, manufacturers and wholesale distributors.
Integrated expertise that provides assurance of compliance with requirements worldwide.
Audits all over the world by experienced internal auditors with strong background in the areas of auditing.
Possibility of combining multi-topic audits to a more complete compliance assurance (e.g., confirm the compliance of your CMO to GMP requirements and to the registered dossier).