OLIC renders services regarding drug regulatory affairs (RA) for a wide range of products, e.g. medicine, medical devices, veterinary products, cosmetics and food. Our solutions are custom-built for each client's project, with the highest of quality in mind. Our team is trained to handle a variety of issues, enabling us to meet strict regulations, deeply understand administrative concepts and provide expertise in strategic planning.
We provide end-to-end support, starting from the primary assessment, by preparing the common technical dossier or electronic common technical dossier and submitting it for approval. Alongside this, we also prepare statements for regulatory authorities, provide regulatory consultancy and post-marketing services as needed, and keep up-to-date on regulation requirements.
Primary Assessment and Analysis
AW Preparation and Review
Follow-Ups and Providing Statements
Major Variation/Minor Variation
Law and Regulation