Regulatory and Quality Consulting
SRS offers comprehensive regulatory and quality services for your company and your products.
We adapt our services to your support needs, providing a few hours of expertese when needed and full time suport when that is needed. For many customers we provide a variable amount and kind of support in long collaborations lasting over years. The clients that hire us appreciate the quick turnaround for questions that arise during the projects.
We provide guidance through the classification steps and regulatory procedures for market access, including strategic advice, project management and the preparation of 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.
Medical Devices
SRS provides regulatory and quality assurance support for Medical Devices, IVDs and combination products:
-
Classification, technical documentation and registration
-
Establishment of quality systems according to EN ISO 13485 and QSR
-
Transition to MDR and IVDR
-
Acting as your EU authorized representative
Quality
We provide quality assurance support, build quality management systems, conduct audits and provide trainings in GxP, ISO standards and other areas.
Our consultants have the experience to act as RP and/or QP on your behalf.
Drug-Device Combinations
With our experienced regulatory pharma and medical device teams, SRS has all the expertise in-house to support your company in the process to establish the necessary documentation for product approval .
Cosmetics
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.
Food Supplements
We can support you on quality solutions and labelling advice for your food supplements as well as registration of FSMP (Food for Special Medical Purposes).