Pharmaceutical Regulatory Compliance For SMEs And How PharmaTrace Can Help To Achieve It

Biopharmaceutical small and medium-sized enterprises and startup wholesalers, packagers, and dispensers are extremely important for healthcare as they are able to bring new treatments and technologies to market faster than larger companies, satisfy the needs that were abandoned for ages, and help to revolutionize the industry in general. However, the sky is not that blue for the pharma SMEs. Next after the burning investment issues linked with high risks for the funding parties, there are problems with regulatory compliance, especially, in terms of relatively new traceability requirements. In this article, we will show how to easily settle these issues with PharmaTrace's fully customizable and cost-effective solutions.

What Is Regulatory Compliance In Pharma?

As healthcare is an extremely responsible field and the safety of the patients is the first priority, laws, and regulations for pharmaceutical companies are also very strict and binding. What is more, they are often updated in accordance with the current market demands and available technologies.

Basically, pharma compliance is the adherence of the pharmaceutical industry, its products, and its marketing practices to the regulations, laws, and guidelines issued by such regulatory bodies as the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other international regulatory agencies. It is a complex process that involves ensuring that all aspects of the pharmaceutical industry, including clinical trials, manufacturing, distribution, advertising, and sales are conducted in compliance with applicable laws and regulations. Compliance also applies to the research and development of new drugs and medical devices. 

Pharmaceutical compliance requires companies to adhere to laws and regulations, as well as industry standards, such as Good Manufacturing Practices (GMPs), Good Clinical Practices (GCPs), and Good Laboratory Practices (GLPs). Companies must also ensure that their processes and products meet the standards set by the relevant regulatory agencies.

What Are The Risks Of Regulatory Non-Compliance For Pharma Companies?

1. Fines and Penalties: Heavy fines and penalties can be imposed by regulatory authorities for non-compliance with regulations. This can be financially devastating for a pharmaceutical, especially a small one. According to the recent Ponemon and Globalscape reports, it is 2.71 times more costly for an organization to not comply with mandates. In the USA, the average cost of compliance is $5.47 million, while the average cost of non-compliance is $14.82 million. The difference is $9.35 million annually.

2. Reputational Damage: Non-compliance with regulations can lead to a tarnished reputation for a pharmaceutical company, which can lead to a loss of trust from customers and other stakeholders.

3. Loss of Licenses: Regulatory bodies have the power to revoke licenses and permits for companies that do not comply with the regulations, which can lead to a loss of revenues and the potential shut down of the company.

4. Litigation: Companies that are found to be in violation of regulations may face civil lawsuits and other legal actions, leading to costly legal fees and potential damages.

5. Criminal Prosecution: In extreme cases, criminal prosecution may be brought against a company that is found to be in violation of regulations. This can lead to further fines and penalties, as well as potential jail time for individuals responsible for the violations.

Pharmaceutical Serialization And Traceability Requirements

While most of the regulatory requirements have been used for ages and companies are well-prepared, serialization and track and trace have long remained at the discretion of the pharma players. These procedures help to prevent counterfeit, and better manage products during their journey in the supply chain.

Basically, serialization is the process of assigning a unique identifier to each individual package of a pharmaceutical product. This unique identifier is stored in a database and can be used to track and trace the product from the point of manufacture through the supply chain. This allows pharmaceutical companies to monitor their products at any point of their route, ensuring that they are not stolen or tampered with. It also enables drug manufacturers to identify counterfeit drugs and help to ensure that only genuine products reach the consumer. 

Track and trace, on the other hand, is the process of following the movement of a product through the supply chain from the point of manufacture to the consumer. This is done by utilizing the unique identifiers assigned to each package during the serialization process.

Most recently the majority of governments have passed laws making serialization and traceability in pharma mandatory for all industry players. For example, EU FMD serialization requirements which are part of the European Union Falsified Medicines Directive (EU FMD), require that all medicines sold in the EU have a unique identifier (UI) in the form of a 2D barcode. This barcode must contain a product code, serial number, and expiry date. In addition, the barcode must be applied to each individual package of the medicine and must be verified at the point of dispensing. Medicines must also be traceable from the point of manufacture to the point of dispensing. Finally, the EU FMD requires that a centralized system be used to manage the data associated with the serialization of medicines.

In the U.S., the Food and Drug Administration (FDA) has passed laws requiring companies to have in place standardized numerical identification for prescription drug packages (GTINs), to secure the supply chain. Each smallest packaging level of a product must be included in a 2D Data Matrix (GS1) data carrier. The next step defined by DSCSA serialization requirements would be aggregation, which means that both drugs and transport units (bundles, pallets, and containers) should be serialized by 2023.

Some companies have already implemented serialization requirements for pharmaceuticals, others are about to do so. That’s why pharma manufacturers, CMOs, wholesalers, packagers, and dispensers notwithstanding their maturity status and size are now obliged to find the right solutions to be able to survive in the market.

And while developed companies are more likely to meet these requirements, as they already have some procedures and people in place, and/or have been building comprehensive traceability platforms for years, SMEs are sometimes lacking even basic knowledge of how to comply, so they need some easy to use, cost-effective and fully customizable pharma track and trace solutions.

PharmaTrace Serialization and Supply Chain Management Solutions

PharmaTrace offers blockchain and AI-backed serialization and supply chain management solutions to help small to medium pharmaceutical companies meet regulatory requirements and improve their overall supply chain visibility. Their solutions include

1. Serialization: PharmaTrace provides a secure serialization service that enables pharmaceutical companies to easily and cost-effectively implement serialization procedures. This includes the generation of unique, traceable codes for each drug package, the ability to check the authenticity of drugs throughout the supply chain, and managing product shortages and recalls.

2. Traceability: PharmaTrace also provides traceability solutions to help pharmaceutical companies ensure the safety of their products by tracking and tracing the movement of drugs throughout the supply chain. Additionally, it also helps to identify and monitor potential risk areas and provides alerts and notifications when non-compliance is identified.

3. Supply Chain Management: PharmaTrace provides supply chain management solutions to help pharmaceutical companies to cope with shortages and recalls. It is capable to analyze inventory levels, predicting customer demand, and optimizing the movement of products throughout the supply chain.

Benefits of PharmaTrace Serialization and Track And Trace App

1. Customized solution: The app provides an end-to-end solution for pharma SMEs, from serializing individual drugs and packaging to monitoring their distribution and sale. It is a scalable solution, so it is possible to start from one or two services you need right now and add new ones when necessary. This approach helps to make the product as lightweight as possible and allows small to medium pharmaceutical companies to save money. Moreover, specific functionality (like drug verification for customers, or a sales platform) and company branding can be added as per request.

2. Cost-effectiveness: The app can help pharma organizations reduce costs associated with manual tracking processes and inefficiencies, and avoid non-compliance penalties. What is more, we do not charge for transactions which means you will not face any hidden charges. The cost of the solution is also usage-based. Our customization approach lets you pay only for services you need.

3. Quick deployment: PharmaTrace's serialization and track and trace app can be deployed quickly (normally, in 4 months) allowing organizations to achieve compliance with minimal disruption to their operations. 

4. Enhanced Patient Safety: PharmaTrace Serialization and Track and Trace App helps to make sure that all medicines are tracked from their point of manufacture to the point of use. It helps to reduce the chances of counterfeiting, product shortages, and recalls, as well as ensure that all medicines are safe and effective for use.

5. Enhanced Regulatory Compliance: PharmaTrace Serialization and Track and Trace App helps pharmaceutical companies to meet the various regulatory requirements and ensure that they are compliant with all current regulations in the locations they and their partners operate. This helps to reduce the risk of penalties, as well as protect the company from reputation loss and potential lawsuits.

6. Better visibility: PharmaTrace's serialization and track and trace app helps manufacturers, wholesalers, and pharmacies stay informed of product movement in real-time. This level of visibility enables them to detect any irregularities and intervene quickly to resolve them.

7. Improved inventory management: PharmaTrace's blockchain-backed serialization and track and trace app helps pharma manufacturers, wholesalers, and dispensers better manage their inventory. This in turn helps to minimize shortages of vital medications and manage the recalls hassle-free.

Apply Now To See The Demo

The PharmaTrace Serialization and Track and Trace app provides a customized solution that helps small to medium pharmaceutical companies settle all their pain issues with regulations, track and trace, serialization, and product management. By providing secure and reliable data tracking, it helps to ensure that medications and devices are safe and compliant, while also giving valuable insights into the distribution and inventory levels. If you would like to know more about our solutions and how they can help to improve your business, please feel free to fill in a short form here and we will get back to you in 24 hours.

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