Biotech Regulatory Solutions is a well established regulatory and scientific affairs consulting company. Our highly experienced team provides professional, high quality, flexible and and all times is solution based to meet all your needs. We are an Australian based regulatory and scientific affairs consulting business. The Principal Consultant (Katy King) and her team have a broad background in regulatory affairs, R&D and drug development within the pharmaceutical industry. Combined experience among consultants is >70 years. Biotech Regulatory Solutions also offers consulting services in the areas of quality assurance, pharmacovigilance and medical information.Katy has over twenty years (19 dedicated to regulatory affairs) experience in the pharmaceutical & allied research sectors of the industry (CSIRO, R&D pharma/biotech companies), with hands-on experience with three international regulatory agencies (TGA, Medsafe and Health Canada). Katy has upheld senior management positions prior to opening Biotech Regulatory Solutions; Director Regulatory Affairs of an international drug development company and Scientific Affairs Manager (Australia and New Zealand) for an International pharmaceutical and medical device company.Specialities: Prescription Medicines Biotech Medicines BiosmilarsGeneric Medicines Literature based submissions OTC Medicines eCTD/NeeS dossier publishingMedical Devices (Class 1, IIa/b & III)Dossier review - gap analysis reports SOPs and systems/process improvements Import Permits State Licenses for distribution and supplyGMP assistanceDrug/product developmentPharmacovigilanceMedical Information