Biotech Regulatory Solutions

Biotech Regulatory Solutions is an established and highly experienced Australian based regulatory and medical/scientific affairs consulting business with a broad background in regulatory affairs, R&D, drug development, medical information and pharmacovigilance within the pharmaceutical industry. In additional provide outsourcing options with regards to promotional material review, medical information and phamacovigilance activities. With over 70 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- with recent successful registations. > Generic medicines – new generics, bioequivalence study management and general maintenance. > OTC medicines – NMA, variations and general maintenance. > Dossier review – gap analysis reports. > Medical Devices (Class II, IIa/b & Class I). > Literature based submissions. > Orphan drug submissions. > NeeS/eCTD > GMP assistance including SOPs and systems/process improvement. State Health Authority Licensing for distribution and supply. > Import Permits.