Who We Are?
Medical Device Regulatory Consultants &
Drug Regulatory Consultants
CMS is a rapidly expanding Regulatory Affairs consultancy firm. We are based in Australia, New Zealand, Europe and UK. With over 20 years of experience in the field of Regulatory compliance, we offer expert guidance and consultation ensuring smooth submissions to meet the local regulatory requirements so as to enable your medical devices to be imported, distributed and marketed globally.
Our expertise qualifies us as a provider of regulatory and follow-up services in the following categories:
- Medical Device Registration
- In Vitro Diagnostics (IVD) Device Registration
- Drug Registration
- Quality Management Services (QMS)
- Cosmetic Registration
We provide constant support through every stage of your product development and we guarantee a smooth-sailing process all the way up till the final stage, product approval. Regardless of your medical area of focus, we will ensure a hassle-free registration process in a timely manner, thus maximizing your product’s commercial potential.
We keep well abreast with the current legislation, evolving regulatory requirements, and new industry initiatives. We have extensive experience and knowledge of regulatory affairs and offer our unwavering support and commitment to meet your regulatory needs.
All our services are offered in-house and not by service partners, ensuring a consistent level of service that is tailored to your firm’s needs, as well as a single point of contact for easy communication.
Dr. Esther Apos
Director
Dr. Esther Apos completed her Ph.D in Biochemistry in 1992 through the Faculty of Veterinary Science at the University of Melbourne. Over the past twenty years, she has worked in academic and commercial research, pharmaceutical and medical device product development, clinical trials, quality assurance and regulatory affairs. Dr Apos established Sci Doc Solutions in 2009 and has worked with numerous biotech and medical device companies, developing their product documentation, quality management systems and dossier registration.