The pharmaceutical industry has specialized needs when it comes to fulfillment for a new pharma product launch. The years of research and millions invested to get a new product cleared for launch to the market is substantial. That’s why it is critical that your launch strategy for a new drug runs like clockwork.
A fulfillment partner does more than just store and ship products – they play a key role in maintaining regulatory compliance, managing complex logistics, and delivering your product efficiently to healthcare providers and patients. The stakes are high, so it is essential to have the right fulfillment playbook in place. From specialized expertise in handling pharmaceuticals to the ability to scale operations rapidly to the flexibility to provide complex print-on-demand documentation, the right fulfillment partner can make all the difference in turning a product launch into a success story. Here are the key things you need to know.
Bulk Order Processing: Managing High Volumes and Precise Timelines
Product launches involve handling large volumes of orders within a short timeframe – to ensure that the products all reach their destinations at virtually the same time. That’s where a fulfillment partner comes in. They are equipped to scale their operations to handle bulk orders, ensuring that the product reaches the market efficiently.
Diamond Fulfillment has a proprietary GDPR-compliant online ordering platform. This platform is designed to meet the intricate specifications and complex business rules required to effectively manage inventory within their organizations. It enables management by the brand, and sales team, and adheres to ordering and budget restrictions set by our clients. Diamond has the necessary data encryption to meet the strict requirements of pharmaceutical products.
Bulk order processing for a pharma product launch requires shipping one or multiple items to a large number of customers in a short time frame. It is vital to have a streamlined process to ensure accuracy and speed. It may also require adjusting standard processes to accommodate changes in order volumes, packaging requirements, or distribution strategies – particularly valuable during the unpredictable early stages of a product launch.
Customers provide a manifest file with the “ship-to” addresses, the item numbers, and the quantities required for the product launch. Once the file is in hand, Diamond Fulfillment can work backwards: planning for transit time for each order can calculate precise shipping dates. These dates are carefully orchestrated so that all orders arrive at their destinations on the same day – no matter where customers are located.
Value-Added Services: Handling Complex, Multi-Item Orders
Fulfillment for pharmaceuticals involves not only the new product or products, but customized documentation, FDA-compliant information, promotional materials, special packaging needs, and more. At Diamond Fulfillment, we have long experience in accurately managing these types of complex products and packaging challenges. We work directly with our clients to identify their customized needs and carefully plan their launch – and manage orders every step of the way, from receipt to delivery. Our customers can rely on our precise policies and procedures to handle the complexities of any custom assembly project. We’ve also dedicated 10,000 square feet of our Chicago-based facility to handle these and other and customized mailing programs.
Diamond Fulfillment also holds an FDA drug-sampling license and can support drug sample kitting and distributions within the US market. Here are some of the other critical value-added services that are the building blocks of a successful launch:
- Custom kitting, with a wide variety of components based on launch needs
- Special packaging including wrapping, shrink wrapping, bagging, and labeling
- Documentation and drug information
- Promotional launch materials, and more
Print on Demand Service: Creating Customized Documentation, Just in Time
Pharmaceutical products require precise and compliant labeling, including drug facts, usage instructions, expiration dates, batch numbers, and regulatory disclaimers. Print on demand (POD) enables pharmaceutical companies to produce labels that meet specific regulatory requirements for different markets or jurisdictions, ensuring compliance without the need for large pre-printed inventories. Diamond offers comprehensive POD capabilities to our healthcare and pharmaceutical clients. Here are some of the many benefits of a POD approach:
- Localization and Customization. With POD, companies can easily adapt labels to meet the language and regulatory requirements of different regions or countries. This is especially important when launching a product globally, where each market may have unique labeling requirements.
- Just-in-Time Production. Print on demand allows for the production of packaging materials exactly when they are needed, reducing the risk of overproduction and obsolescence. What’s more, it reduces lead times.
- Batch-Specific Customization. POD enables batch-specific information to be included on packaging, such as batch numbers, expiration dates, or special handling instructions.
- Reducing Waste and Lowering Inventory Costs. Traditional printing methods require large print runs to be cost-effective, which can lead to excess inventory and waste if the packaging or labeling needs to be updated.
Strict Regulatory Compliance: Fulfillment houses, like DIamond Fulfillment, that specialize in pharmaceutical products are well-versed in the regulatory requirements for storing, handling, and shipping medications. We ensure that all aspects of the fulfillment process meet strict industry standards, which is crucial for maintaining compliance with laws and regulations.
- Facility Standards. Good Distribution Practice (GDP) standards and GMP standards for Food includes proper storage conditions such as temperature control, humidity control (if applicable), security measures, cleanliness, and segregation of pharmaceutical products to prevent cross-contamination.
- Quality Management. A fulfillment provider should have a robust quality management system. For example, Diamond is ISO 9001:2015 certified. We are HIPAA compliant, NABP compliant and on the path for NABP certification. We are FDA-registered for both Food & Drugs.
- Temperature Control & Monitoring. The ability to monitor and control temperatures throughout the entire process – from storage to kitting is key. This means controlled storage areas, calibrated temperature monitoring equipment, and procedures for handling temperature excursions.
- Validation & Certification. Diamond validates and qualifies our processes and equipment to ensure they consistently meet regulatory requirements. This includes calibration of temperature-controlled storage areas, and equipment used for handling pharmaceutical products.
- Security. Comprehensive security measures must be in place to prevent theft, tampering, or unauthorized access to any pharmaceutical products. This may include access control systems, surveillance cameras, and procedures for verifying the identity of personnel and visitors.
- Documentation & Record Keeping. This is paramount for the pharmaceutical industry. At Diamond, we keep accurate and complete documentation – including records of receipt, storage, handling, and distribution activities, including batch/lot numbers, expiry dates, and any deviations or incidents that occur.
- Audits & Inspections. Diamond welcomes audits and inspections by regulatory authorities or their clients. We are prepared to demonstrate compliance to applicable regulations and standards during these audits.
- Training. Diamond personnel involved in handling pharmaceutical products receive appropriate training on GDP requirements, safety procedures, and any specific requirements related to the products they handle.
Conclusion
Diamond Fulfillment Services has the people, the know-how, and long-time expertise in the pharmaceutical industry. In fact, we’ve executed more than 500 successful brand and product launches on behalf of our clients. Let us help make your next pharma brand launch a roaring success too! At Diamond Fulfillment, we believe our customers deserve the best – and we’re always willing to share our technology and expertise to help you get what you need. To find out how Diamond Fulfillment can help you with warehousing and fulfillment solutions or to get a tour of our fulfillment centers in Chicago, contact us today or by phone at 847-856-7700.