NADRACT is a leading Regulatory affairs services company and has been a pioneer in providing strategic multidisciplinary Regulatory affairs consulting services across Australia. NADRACT provides comprehensive Regulatory affairs services the spectrum of Dossier submission, Variation applications, Gap-analysis reports, and Regulatory support throughout the life-cycle of product, Declaration/Maintenance of product annual charges, PBS applications, TGA GMP clearance and Representation of overseas.

By pooling our collective experiences and expertise, the regulatory affairs consultants team represents a formidable resource to support client with registration of medical devices, maintenance of product registrations, liaise with the TGA &/or Medsafe and regulatory enquiries.

All regulatory affairs consultants are seasoned industry executives who have spent their careers working with pharmaceutical, neutraceuticals and therapeutics companies for registration and maintenance of registrations including over-the counter medicines, complementary medicines, prescription medicines, veterinary medicines, consumer goods, cosmetics and medical devices. NADRACT’s regulatory affairs consultants have particular expertise in Australian Therapeutic Goods Administration (TGA) and New Zealand Medsafe requirements and have many years’ experience managing regulatory processes in the region.

NADRACT’s Regulatory affairs services enable large, medium, small and startup pharmaceutical companies to understand and efficiently manage the demanding complexity of the diverse regulatory requirements in compliance to industry standards.

You can call us at +61 (0) 3 831 34832 or visit our website www.nadract.com.au and have a meeting scheduled with our regulatory affairs consultants.