Regulatory affairs can be frustrating, expensive and time consuming. 

Not every company can afford an in-house RA Officer who will take care of all the delicate work of Quality Assurance, product registration, or proper document submission…

Our QA/RA Consultancy works with and for you

Offering a wide range of outsourced quality assurance and regulatory affairs service, with the quality and dedication of an in-house officer.

CE Marking

CE Marking and timely registration in other countries and worldwide markets.

FDA Submissions and Reviews

Contract services, drug and medical device submissions, post-approval issues and local agency services.

ISO Consulting

ISO 13485 / ISO 9001 consulting and additional quality auditing, marking and control.

Extensive industry experience
Proven Regulatory Strategies

Our seasoned RA & QA team consists of specialists with a high level of expertise within Regulatory Affairs and Quality Assurance of Medical Devices.

We can assist your company with defining and implementing the regulatory strategy of new or innovative medical devices – from idea to marketing.

Dr. Harold E. Braustein, Ph.D.

Diplomate Engineer, QA/RA Consultant

Experienced in Medical Devices, with a large regulatory record in ISO, FDA and CE
regulation demands. Lead auditor and consultant for companies local and abroad.