Sci Doc Solutions is based in Melbourne, Australia and works with companies and organisations to provide solutions for Research & Development, manufacturing, quality assurance and clinical research. Read on for some kind words from our clients:
Dr Esther Apos has been working part time with Ramsey Coote Instruments for the past several years. During that time she has been involved in a variety of projects including developing the quality management system that need to comply with ISO 13485 for medical devices, write up of the process for manufacturing and various policies within our QA system and she has co-ordinated and project managed a clinical research project that involved a multi-centre audit with seven different practice settings. This also required ethics approval from various committees and was recently completed. The research was written up by Dr Apos collaboratively with the other investigators and has been submitted for publication.
I would highly recommend Dr Apos to work on these type of projects as she approaches her tasks in a diligent and enthusiastic manner.”
Ramsey Coote Instruments
I have known Esther for over five years, and for the last two she has been working on the establishment of the Australian Spine Registry. Throughout this time Esther has always conducted herself in a professional manner and accomplished her tasks punctually and with an outstanding level of detail. This project has been challenging for all involved, starting a registry “from scratch” being no simple task. Esther has been required to work around issues of ethics, budgets, bureaucracy and pre-existing structures, and engage a group of people from disparate backgrounds and skills to work together to achieve the goal of the registry. Esther is an outstanding project manager and “real world” researcher and I would highly recommend her to any prospective employer.
Orthopaedic Spine Surgeon
BSc(Hons) MBBS MClinEpi FRACS FAOrthA
Spine Society of Australia
“I have worked with Esther and Scientific Document Solutions for more than 12 months and within this time Esther has become a valued member of our team. Esther consistently delivers quality outputs and has the ability to visualise future issues and manage them ahead of time.
Esther is efficient, professional and a delight to work with”.
Livac Pty Ltd
I have worked with Esther from afar (I am based in the UK) on QA and RA related projects.
Specifically Esther achieved ISO 13485 and CE Mark for her clients, and also guided her clients to Health Canada CMDCAS Certification.
Esther has a deep understanding of the Quality and Regulatory requirements for the EU, Australasia and Canadian sectors, and I have enjoyed working with Esther for over four years, and look forward to many more years of collaboration.
I strongly recommend anyone seeking ISO 13485, CE Mark, and/or Canadian compliance to allow Esther to support you on your path to total compliance.
Certified IRCA Principal Auditor