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acrapack regulatory consultancy recommendations

We are committed to supporting our clients in the medical, biotechnology, lifescience and healthcare industries maintaining high standards and providing complete solutions for Quality, Regulatory and Compliance challenges. See what our clients have to say.

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. May 5, 2010

Top qualities: Personable, Expert, High Integrity
Geoffrey Wanless hired Anne in 2008.

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. May 9, 2010

Top qualities: Great Results, Expert, High Integrity
Barry Evers-Buckland hired Anne in 2009, and hired him/her more than once.

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. May 5, 2010

Top qualities: Great Results, Expert, High Integrity
David Thomas hired Anne in 2006.

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. April 28, 2010

Top qualities: Expert, Good Value, High Integrity
Christine CUTHBERTSON hired Anne in 2009, and hired him/her more than once.

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. April 28, 2010

Andrew Bradley (Chief Technology Officer at Ausonex) managed Anne at Ausonex Pty Ltd.

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. May 5, 2010

Top qualities: Great Results, Expert, On Time
Sian Stubbs hired Anne in 2007.

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

Let Acrapack assist you with your quality system development or regulatory activities



 
 
 
 
 
Acrapack is proud to be a member of the following associations
 
AusBiotech - Australia's Biotechnology Organisation IVD Australia Science Industry Australia Association of Therapeutic Goods Consultants
 
   
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