Pharmaceutical dossier preparation is an important part of our role in helping navigate our customers through the product’s adaptation, formatting and translation. We understand that a consistent and compliant regulatory dossier is the key to obtaining timely registration approval in the territories. However, many times the path to approval may be filled with challenges and difficulties and that’s where our dossier regulatory development team makes a difference, helping partner accelerate or optimize the drug approval process.

For more than 10 years we have collected a wealth of information from local market regulatory intelligence and expectations from the various NRAs in the region that are not necessarily listed or publicly disclosed. It takes human contact, building professional relationships and understanding cultural differences even among local neighboring countries, to offer unparalleled experience and insightful support. Our staff is knowledgeable in preparing regulatory submissions for all types of medicines, from chemical drug products to biotechnology drug products such as vaccines, monoclonal antibodies, Immunotherapies, blood products, recombinant drugs, orphan drugs and stem cells.

Our regulatory experts also have extensive experience of regulations covering drug substances, both small and large molecule, pharmaceutical excipients, herbal and vitamin and mineral products, and medical devices.