Acrapack regulatory consultants who we are
Acrapack (regulatory consultants) are a Queensland based consulting company, established in 2005 by Anne Jones, our principal Quality and Regulatory Consultant and Director.
Acrapack is committed to supporting companies in the medical, lifescience, biotechnology and healthcare industries and to maintaining high consulting standards by providing complete solutions for Quality, Regulatory and Compliance challenges.
We provide regulatory and quality assistance on registration and compliance requirements for Medical Devices, Invitro Diagnostics (IVDs), Food, Cosmetics, and Medicines.
Anne is an experienced scientific and technical affairs specialist, with 25 years management experience and an exceptional track record in delivering high level quality and regulatory systems in the healthcare industry, with a sound regulatory knowledge from development to post market.
With knowledge of the critical aspects of business which influence product quality and compliance, Anne is particularly committed to ensuring efficient development of processes and quality designed productsto achieve a balance between risk and commercial rewards and ensure the Quality Management System supports the business needs as well as meets regulatory compliance.
Acrapack is proud to be a member of the following association
Regulatory Affairs and ISO 13485 expert
“Anne is prompt and efficient in all aspects of the work that she carries out for our medical company in regards to our regulatory requirements with the TGA. She demonstrates an in depth knowledge of the processes and requirements. We look forward to continuing our solid relationship.”
August 20, 2014
Top qualities: Expert, Good Value, On Time
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ACRA regulatory services as your Medical Device sponsor in Australia or New Zealand or in both countries
Acting on your behalf to register your medical device by communicating with either the Therapeutic Goods Administration (TGA) or Medsafe in New Zealand or both and carrying out obligations placed on the sponsor in relation to medical device or IVD device registrations, in order to meet and show compliance with the regulatory requirements in both countries.
Find out more about how we can assist as your Australian or New Zealand sponsor or as your sponsor for both countries