Compliance Solutions

At Knipper, we have dedicated departments for Quality Assurance, Regulatory Compliance, and Legal. All three report directly to our CEO.

The Knipper Advantage in Compliance

Knipper’s Regulatory Affairs team comprises industry experts with significant years of experience from numerous pharmaceutical companies and other highly regulated environments. Members of the team have diverse, multifaceted backgrounds in science, law, business, and information technology. These experts are well versed with respect to regulatory and compliance matters encompassing drugs, medical devices, controlled substance, List I chemicals, PDMA, cGXP, 21 CFR Part 11, HIPAA, and OIG. Knipper’s Regulatory Affairs team also has expertise in a broad range of matters in the area of healthcare marketing such as state laws governing unsolicited faxing, CAN-SPAM, gifts to physicians, alternative sampling, and product distribution. We educate others in the industry through various speaking engagements at conferences, symposiums and one on one consultation.

Knipper's Regulatory Solutions

Through such breadth of knowledge and experience, Knipper’s Regulatory team can provide a full range of regulatory consulting services for the healthcare industry. We can advise on marketing practices and strategies, as well as perform compliance audits, all aimed to help companies steer through the complex and interrelated legal, regulatory, and business requirements.

Our regulatory team is regularly called on to assist in the following areas:

• Educating pharmaceutical executives on emerging laws and compliance requirements to enable them to make informative business decisions;
• Develop a compliance strategy to abide by both federal and state laws;
• Perform PDMA training for pharmaceutical sales representatives;
• Review and develop corporate standard operating procedures;
• Perform independent audits of their facilities to identify potential compliance gaps and propose any curative action; and
• Validate systems to ensure compliance to 21 CFR Part 11 and HIPAA security requirements.