PROFILE
As a small company with extensive practical industry experience, services are tailored to meet customers' specific needs and timelines. Dorian Regulatory Affairs intends to be your partner in optimising the registration package and strategy, and can assist in obtaining (or maintaining) a marketing authorisation at the earliest possible time.
The company operates in a network environment with contacts in all EU countries, Switzerland and the US. Through a network of colleague consultants, active in related fields such as medical writing, GMP, toxicology and eCTD publishing, additional services that may be required to successfully develop and register a product can be arranged.
Subcontractors will operate under the responsibility of Dorian Regulatory Affairs unless it is mutually beneficial to arrange direct contracts with the client.
Providing strategic advice is among the core competencies. Opportunities such as orphan drug designation, SME status, scientific advice/protocol assistance and presubmission meetings with the EMA and/or national agencies are considered, as well as the timely submission of a Paediatric Investigation Plan.
Dorian Regulatory Affairs can handle the entire regulatory procedure for the client, including related activities such as arranging tradename review, ATC request, product information translation etc.
About half of the products handled by Dorian Regulatory Affairs concern biotechnology or advanced therapy products. Dorian Regulatory Affairs has also been involved in registration of radiopharmaceuticals and blood products.
