Regulatory

At Benchmark Biolabs, our highly experienced staff works to assure that appropriate standards are maintained. Benchmark Biolabs offers a full range of Quality Assurance (QA) and Regulatory Affairs (RA) services to accelerate our clients’ projects.

Comprehensive QA Services

• Internal system audits
• Audits of study data and final reports
• Vendor audits
• Document control
• Staff training – compliance and quality improvement
• QA consulting

The Regulatory Affairs group at Benchmark Biolabs has extensive knowledge about the regulation of biological products to provide up-to-date advice on plans that result in timely, cost effective and successful product licensing. Benchmark Biolabs provides a range of regulatory activities, including preparation and submission of required documents. Benchmark Biolabs has excellent relationships with regulatory authorities, and can contact them with or on behalf of our clients. Avoid costly regulatory delays with our value-added service throughout or at specific points in product licensing.

Regulatory Affairs Services and Expertise

• Effective communication with regulatory authorities
• Expert development of product-licensing plans
• Preparation and maintenance of regulatory submissions
• Regulatory strategies to facilitate product authorization
• Skilled technical writing