Biotech Regulatory Solutions

biotech regulatory solutions is an australian based regulatory consulting business with a broad background in regulatory affairs, r&d and drug development within the pharmaceutical industry. with over 50 years combined experience in the pharmaceutical and allied sectors of the industry, biotech regulatory solutions consultancy provides professional services tailored to assist your regulatory needs. biotech regulatory solutions provide professional, high quality service that is flexible and solution based to meet your needs. we provide the following regulatory consulting services: > prescription medicines – nce, line extensions, major variations and general maintenance. > biotech medicines – new entities, line extensions, major variations and general maintenance. > biosimilar medicine registrations > generic medicines – new generics, bioequivalence study management and general maintenance. > otc medicines – nma, variations and general maintenance. > dossier rev