Regulatory Solutions

Design Group is a leading supplier of validation and regulatory consulting services to the biotech, pharmaceutical, and medical device industries. Combining the GAMP life-cycle methodology with strong internal procedures, our validation and regulatory service teams deliver flexible and diverse validation packages.

Our broad capabilities encompass master planning, specifications and commissioning, as well as protocol development, execution, and summarization for a variety of systems. In addition to comprehensive quality system audits, Design Group conducts 21CFR-11 gap analyses and implements remediation programs.

Our Regulatory Services include: