Regulatory and Quality Consulting
We offer comprehensive regulatory and quality services for your products.
With our flexibility we can support with a few hours when needed or long collaborations lasting over years. The clients that hire us appreciate the quick turnaround for questions that arise during the projects.
We guide you through the classification steps and regulatory procedures for market access, including strategic advice, project management and preparing documentation for submission.
We provide support in handling the day-to-day communications with the health and regulatory authorities as well as support and maintenance for product variations, renewals and other post-approval activities.
We provide regulatory and quality assurance support for both Medical devices and IVDs for CE certifications as well as registrations in other markets.
We can act as your EU Authorised Representative and guide you in the transition process to the new Medical Device Regulation (MDR) as well as help you with your quality systems.
With our experienced teams in both pharma and medical device regulatory, SRS has all the expertise in-house to support your company in the process to establish the necessary documentation for product approval of products regulated by both pharmaceutical and medical device legislation.
The Cosmetics Regulation (EC) No 1223/2009 applies to all cosmetic and hygienic products, both those manufactured in EU and those imported into EU. We help manufacturers, importers and distributors to meet the requirements of the Cosmetics Regulation.
We can support you on quality solutions and labeling advice for your food supplements as well as registration of FSMP (Food for Special Medical Purpose).