Acrapack Regulatory Consultants

Dedicated regulatory professionals offering a high quality consulting service

Acrapack Regulatory Consultants – What We Do

Dedicated regulatory professionals offering a high quality consulting service that supports and provides the objectivity to get the work done.
  • Regulatory advice and consulting support for post market requirements
  • Strategic Planning for Australian and international Medical Device and Invitro Diagnostics (IVDs) regulatory and quality system requirements
  • Prepare and review of Medical Device and Invitro Diagnostics (IVDs) regulatory submissions
  • Medical device and Invitro Diagnostics (IVDs) Technical dossier reviews
  • Submit Medical Device and Invitro Diagnostics (IVDs) regulatory submissions, Australian TGA Class III and Conformity Assessment submissions
  • Prepare new product regulatory and quality system documentation to support Australian Medical Device and Invitro Diagnostics (IVDs) projects
  • Prepare Medical Devices and Invitro Diagnostics (IVDs) Technical Files
  • Gap analysis for ISO 13485 Quality Management System and MDSAP
  • Process and Systems reviews
  • Implement integrated ISO 13485 and FDA quality management system requirements (QMSR)
  • Internal quality system audits
  • Medical Device and Invitro Diagnostics (IVDs) Supplier due diligence and assessment audits
  • Medical Device and Invitro Diagnostics (IVDs) Product labelling reviews

Call Acrapack today on +61 400 284 808.

Contact Acrapack

“For anyone seeking medical regulatory advice with regard to TGA or FDA compliance or who is considering launching a new medical device or pharmaceutical Anne’s assistance can be invaluable. Anne works seamlessly with an organization’s internal development teams to deliver results on time and above expectations. As CEO of Ausonex, I engaged Anne to support our business in developing a new medical device and commend her contribution.”

Top qualities: Personable, Expert, High Integrity
Geoffrey Wanless
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If you are an overseas company with no physical location in Australia or New Zealand, you will need an Australian sponsor or New Zealand sponsor or both for compliance to the regulations and for the registration processes in both countries. We offer Australian sponsor and New Zealand sponsor services under ACRA Regulatory Services.

Call Acrapack today on +61 400 284 808.

Contact Acrapack

Let Anne and Acrapack assist you with your regulatory and quality challenges, or with your quality management system development.

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