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Helping You

Conform To Various Regulatory Guidelines

With Regulatory Solutions, Inc. your company can always remain compliant with the medical device manufacturing standards and regulations set by regulatory authorities. With our more than 25 years of experience in the field, we can be trusted to provide full-service, reliable consulting and support to biotech companies all over the world.

Medical Devices

Our Expertise

We are knowledgeable in manufacturing Medical devices for a wide array of diagnostic Devices, including ELISA, CLIA, IFA, Rapid, serology Test kits and instruments. With this, we can help clients with fulfill their regulatory compliance obligations, such as:

  • FDA QSR Documentation and Implementation
  • ISO Standards QMS Documentation and Implementation
  • QMS Gap Analysis and Certification
  • EC Directive Requirements
  • IVD to IVDR Transition
  • The Medical Device Single Audit Program (MDSAP)
  • Onsite and Offsite Internal Audits
  • Global Unique Device Identification Database (GUDID) submission

Our Solutions

We offer comprehensive regulatory solutions that are in line with our clients’ goals to reach greater heights and serve an international market. These include the following:

  • ISO Services
  • FDA Services
  • CE Services
  • Health Canada Licensing
  • California FDB Services
  • European Certificates
  • Registration documents Services
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Our Commitment

At Regulatory Solutions, Inc. we are always dedicated to helping businesses meet the facility registration requirements demanded by various authorized agencies. To do this effectively, we will always ensure that every application is prepared and submitted completely and on time. Apart from this, we will also closely work with regulatory organizations, such as the FDA and ISO, on a regular basis.

Let Us Handle Your Regulatory Compliance Needs

With our extensive expertise, you can count on us to handle any concern with utmost excellence and dedication. For more information, feel free to get in touch with us today.