The Situation …
In the pharmaceutical and biotech industry, compliance is a serious matter with potentially very serious repercussions if it is not managed properly.
The regulatory landscape is constantly shifting as the federal government adds new layers of complexity and individual states continue to add their own unique standards. In response to these challenges, more and more life science companies are looking to outsource their compliance management to experts who are singularly focused and highly trained to manage this critical facet of drug sampling. The key of course is choosing the right compliance partner.
Critical Challenges …
- The most critical factor of effective, cost efficient compliance within every hand carry initiative is an exceptional Sample Accountability program. And for that, you want help from a highly experienced partner with a proven track record of excellence.
- Your salesforce needs direct access to a team of experts who proactively help them avoid reportable incidents and respond quickly to their needs in the field.
- Your team needs clear visibility to highly accurate PDMA compliance data, efficient processing of reconciliations, skilled handling of variances, and timely state and federal reporting.
- You need prompt, reliable and accurate Field Audit and Inventory Services that integrate directly with your sample reconciliation data to maximize cost effectiveness.
Knipper Solution …
With nearly 30 years of experience in the industry, providing Sample Accountability services to the largest outsourced segment of pharmaceutical field sales representatives in the country, Knipper is the undisputed leader in PDMA compliance services in the US. From pharmaceuticals to biologics to the ever increasing needs of medical device manufacturers, Knipper’s sample compliance services include …
- Sample Accountability: Complete sample management, reconciliation and reporting services featuring Knipper’s proprietary Sample Inventory Management System – SIMS™. SIMS integrates all sample-drop and DTP activities providing one source for comprehensive data management, reconciliation, and sample reporting.
- Integrated HCP Validation, SDF Management and Signature verification, as well as random and for-cause audits.
- Field Audit and Inventory Services: Nationwide service including audits, closeouts, and asset recovery as well as integrated storage management solutions.
- State and Federal Reporting Services: Comprehensive handling of any potential reportable incidents such as theft, loss or concealed shortage with guidance provided for resolution.
- Regulatory Consulting Services: Including SOP development, SA program development, and PDMA/FDA Training.
With the industry’s most trusted team of experienced professionals managing your compliance, you can rest easy and focus more of your attention on your sales force’s primary objectives. Click here to request additional information on our Compliance Services.
For nearly 30 years the pharmaceutical, biotech, and medical device industries have been entrusting their sample management success to J. Knipper and Company, Inc. – the largest supplier of samples management services in the U.S, today.