When you think about it, a contradiction plagues your company and the pharmaceutical industry.
Your mission is to serve patients by developing and distributing drugs that combat and manage disease states and help extend and prolong life. Helping patients access these efficacious new drugs as quickly and safely as possible is a priority.
That’s exactly why the pharmaceutical industry is highly regulated. It must be. Medicines and treatments can have an enormous effect on the lives of patients, and drugs in the wrong hands constitute a risk that public health policy must safeguard.
What If the FDA Walks Through Your Door?
Indeed, the stakes are high, so much so that the ramifications of not complying with regulatory affairs in pharma can be serious. They can lead to significant financial judgments, legal and criminal consequences, and reputational risk as well.
So here you are, challenged to innovate. Yet all the while you must monitor risk because the risk of non-compliance stands side-by-side with the compliance demanded by governing bodies and regulatory agencies.
The only way to operate, then, is with a thorough understanding of the laws and regulatory requirements that govern pharma and the ever-changing regulation and how it applies to your company. You must expect that regulatory scrutiny occurs across all your operations, including sales and marketing, drug price reporting, patient privacy, clinical operations, and manufacturing—and to the extent that business operations, financial services impact those policies, rigorous scrutiny must take place there as well.
Compliance on Steroids and Enterprise-wide
You must prioritize compliance at an enterprise level. Rather than settling for siloed views of regulatory issues in which your individual teams are responsible for ensuring compliance, you must build an enterprise-level view of what’s happening with regulatory issues. There’s an amazing machinery behind the scenes and much detail in that level of oversight and documentation, even more so if your company is large or global. That puts compliance in a priority ranking as a sustainable process—one that provides value and ROI.
The good news is that technology has become a huge resource for mitigating risk and decreasing opportunity for error. And the use of big data in pharma has opened up a world of possibility across your organization from research and development to marketing.
In pharma sales and marketing alone, areas in which PDMA, DEA, 21 CFR Part 11 require physician credentialing and validation, and proof of order and receipt, technology portals have enabled DTP drug sample delivery by generating processes for order and receipt, AOR or AOC acknowledgement.
So Much to Manage
Here are just some areas that need compliance oversight.
- Sarbanes-Oxley Act (SOX) – Requires an annual audit to provide proof of accurate and secured financial reporting and compliance for the preceding 90 days.
- Affordable Care Act (ACA) – Requires drug-sample reporting to monitor quantities of drug samples requested
- CRO’s – CRO contracts and execution require monitoring
- Terminal Distributor of Dangerous Drugs (TDDD) – Ohio requires entitiesthat include hospitals, pharmacies, EMS organizations, laboratories, nursing homes, and prescriber practices to show TDDD licensure allowing them to purchase, possess, and distribute dangerous drugs at a specific location
- Deviations – Deviations occur when for whatever reason a procedure wasn’t followed…requirements include identifying what it was, why it was, and establishing the fix and preventive, and doing so in 5 and 30 days respectively
- Supply Chain Issues – COVID’s impact on UPS, FEDEX, and the P.O. have caused drug samples to go astray. Digital systems send up red flags for lost shipments to prevent the risk of drugs being sold on the black market
Synergistix: Providing the Depth of Compliance Rigor You Need
It takes vigilance across the enterprise and an enterprise-wide data flow system to enhance the compliance of day-to-day business activities. Digitized, data flow across the organization integrates all functions and departments into a single system to streamline information, synchronize reporting, and provide automation across the entire organization. Technology enables real-time business information to flow through many different business processes and ensure you say what you do, do what you say, and monitor the business and enforce your business rules and processes.
That’s why we’re here and how we can help. We were built as a company to enable and ensure and level up compliance through technology. We’ve been in the business for 25 years and have never encountered issues with the FDA. In fact, our company was founded and continues to employ not only expert technologists but also professionals who know and understand the ins-and-outs of pharmaceutical industry compliance requirements. Plus, we have a 24/7, stateside call center to answer your questions and address difficulties.
We Got This
We respect the fact that your company does things a little differently than other companies. We introduce our basic system, which is easily configurable with your system, or immediately enhances your processes if they are manual. We can uncover all the gaps that put you at risk and provide the oversight to ensure you mitigate risk by customizing your system to operate more efficiently and safely.
Imagine if you could focus on innovation and pair it easily with your compliance processes. Imagine if you didn’t have to worry about regulation because we were taking the need to worry out of your operations. Imagine if risk mitigation became seamlessly integrated with your day-to-day operations.
Imagine if you could say Synergistix has your back.
Your work is not just about growing your pharmaceutical business and not about making HCP’s look good to patients.
At the end of the day, it’s patients and the greater good you’re serving and protecting by your rigorous compliance.
Call us and ensure you’re providing patients with the medications and treatments that will help them manage diseases and conditions, make their world better, and prolong their lives.