“Anne provides good value for the work she produces”
Anne provides good value for the work she produces and understands the clients requirements. She is able to provide guidance and ideas which maybe surprising when reviewing the restrictive regulatory guidelines.
Michael Micallef
Regulatory Affairs Manager at Health World Limited
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Regulatory requirements with the TGA
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.
Top qualities: Expert, Good Value, On Time
Robert Yee
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“invaluable asset with her connections and consultation experience and skills”
CEO at San Acupuncture Supplies & Equipment
Anne has been a invaluable asset with her connections and consultation experience and skills. Highly recommended, thanks Anne!
Russell O’Reilly
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“Anne is a highly knowledgeable and efficient RA/QA Consultant”
Regional Regulatory Affairs Director, Asia Pacific at Molnlycke Healthcare
Anne is a highly knowledgeable and efficient RA/QA Consultant who always provides comprehensive recommendations and assessments. She has helped our company obtain registrations including Class III medical devices in Australia without issues and in a timely manner. Her passion for her profession is commendable and I would recommend her services to anyone.
Lee Choon Ng
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“Anne’s knowledge,assistance and process oriented approach has been invaluable”
Category Manager CD / AP at Thermo Fisher Scientific
Anne’s knowledge,assistance and process oriented approach to ensuring that Thermo Fisher Scientific is compliant to the new TGA IVD regulations has been invaluable. Anne has set out a schedule that is manageable without being onerous and continues to keep the project on track.
Maree James
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“Anne achieves excellent results and is always responsive to our needs”
Chief Executive Officer at HALO Medical Devices
Anne has provided our company with the regulatory process which enables us to enter the Australian and overseas markets. I recommend Anne on her knowledge and attention to each process required to achieve regulatory approvals. Anne achieves excellent results and is always responsive to our needs. Anne has been a pleasure to work with and I highly recommend her service.
Hayley Warren
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“I recommend Anne and Acrapack without any reservation”
Co-founder and Member of the Board of Directors
Anne was of great help to Saladax in obtaining product registration in Australia. She is highly knowledgeable of the regulations, she outlined a clear plan of action and implemented it with great efficiency. I am sure that we will continue our collaboration and I recommend Anne and Acrapack without any reservation.
Adrienne Choma
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TGA registration process for medical devices
Principal Macarthur Cook Group, Director IVD Australia Ltd
Anne’s knowledge of the TGA registration process for medical devices is excellent. Without Anne’s efforts we would not have the products listed on the ARTG. Without hesitation I would recommend Anne to others requiring regulatory assistance.
Patrick Cook
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Good knowledge of devices and guidelines
Project Manager, Regulatory Affairs at Janssen, Pharmaceutical Companies of Johnson and Johnson
Anne is meticulous in her work. She has a very good knowledge of devices and guidelines and I found her to be exemplary as a manager. She would set an example for her team to follow.
Peter Zuccolotto
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Medical regulatory consultancy
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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Regulatory Affairs and ISO 13485 expert
Anne is a knowledgeable regulatory affairs person who also is an expert in ISO 13485. These two combine to make her very desirable when it comes to working with both Australian and overseas manufacturers and distributors.
Top qualities: Great Results, Expert, High Integrity
Barry Evers-Buckland
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Consultant
Anne is very good at her consultancy work and always supplies the company with the correct information in a timely manner; I would highly recommend her to anyone looking to engage a regulatory consultant.
Top qualities: Great Results, Expert, High Integrity
David Thomas
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Regulatory & Quality Compliance
Anne is a detail-oriented manager who has significant experience in developing and implementing Quality Systems, she works well with our clients training and promoting discussion in order to expand their understanding of the device requirements. Anne is patient and provides ideas to help in problem resolution. Anne also undertakes regulatory activities such as device registration and delivers good outcomes.
Top qualities: Expert, Good Value, High Integrity
Christine CUTHBERTSON
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Quality and Regulatory Officer at Ausonex Pty Ltd
Anne helped guide Ausonex through the ISO 13485 documentation, FDA regulations and risk analyses. Anne is highly experienced in the manufacturing and wet sciences area, and was capable of readily applying her knowledge and experience to the areas of hardware and software design for medical devices.
Andrew Bradley (Chief Technology Officer at Ausonex) managed Anne at Ausonex Pty Ltd.
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Regulatory project management for medical device
Anne looked after a tricky transition registration for one of our medical devices. She was happy to resolve each hurdle and kept me informed all the way. It was a pleasure to have someone take ownership and see the project through to the end, especially since I was busy with other projects.
Top qualities: Great Results, Expert, On Time
Sian Stubbs
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Complex compliance advice and solutions
Survival have created a range of innovative and functional first aid products. Acrapack has assisted us for over 4 years with complex compliance advice and solutions for Oceania, US, UK and EU markets and is now an integral part of our successful business model. I highly recommend the skills and competence Anne Frances Jones and Acrapack offer.
Jerry Tyrrell, CEO
Survival Emergency Solutions
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