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
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