Katy King's Contact Details

Katy King's Company Details

Biotech Regulatory Solutions

Sydney, New South Wales, Australia • 1 Employees
Pharmaceuticals

Biotech Regulatory Solutions is an 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, lineextensions, major variations andgeneral maintenance.> Biotech medicines – new entities,line extensions, major variations andgeneral maintenance.> Biosimilar medicine registrations- with recent successful registations.> Generic medicines – new generics,bioequivalence study managementand general maintenance.> OTC medicines – NMA, variations andgeneral 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.