Compliance Solutions
With a wide breadth of industry knowledge and experience, Knipper's Legal & Regulatory team provides a full range of consulting services for the healthcare industry. We advise on marketing practices and strategies, perform compliance audits, and provide Sample Accountability programs, all aimed to help companies steer through the complex and interrelated legal, regulatory, and business requirements landscape.
Compliance team members have diverse, multifaceted backgrounds in science, law, business, and information technology. They provide regulatory compliance expertise in marketing, handling, storage, fulfillment, and reporting for drug, medical device, DEA, FDA, PDMA, cGxP, 21 CFR Part 11, HIPAA, and OIG.
Knipper's Sample Accountability is best-in-breed, combining regulatory credentials with a robust data infrastructure. Our systems are highly configurable, and accommodate interfaces with many salesforce automation tools. Knipper is one of the leading organizations in SA, servicing more than 6,000 representatives.
- Sample accountability for PDMA compliance
- Program design consultation
- SDF management
- SDF processing
- Reconciliation
- Random and for-cause audits
- Practitioner validation
- Signature verification programs
- Fully integrated with industry
standard SFA systems
- Crisis management and recall services
including "dear doctor" letters and
REMS communications - Regulatory and quality assurance consulting
- SOP development
- Sample recovery and audits
Our regulatory group is often called upon 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.
Strong Heritage
