Certifications & Registrations

All three Meridan facilities are registered with the FDA as pharmaceutical packaging and labeling operations under 21 CFR Part 207. FDA registration is a fundamental regulatory requirement for any facility that manufactures, repackages, relabels, or salvages drug products intended for commercial distribution in the United States. Registration ensures that the FDA has visibility into all facilities handling regulated products and can schedule inspections as part of its risk-based surveillance program.

Meridan operates all packaging and labeling activities in full compliance with current Good Manufacturing Practice regulations as defined in 21 CFR Parts 210 and 211. These regulations establish the minimum requirements for manufacturing, processing, packing, and holding of pharmaceutical products, covering personnel qualifications, building and facility design, equipment maintenance, production and process controls, laboratory controls, and records and reports. cGMP compliance is verified through regular FDA inspections and is a prerequisite for any pharmaceutical customer considering a contract packaging partner.

All three Meridan facilities hold ISO 9001:2015 certification, the internationally recognized standard for quality management systems. This certification demonstrates that Meridan has implemented a systematic, process-based approach to quality management that encompasses customer focus, leadership engagement, process optimization, evidence-based decision making, and continuous improvement. ISO 9001 certification is independently audited and renewed annually, providing customers with third-party assurance of Meridan's quality management maturity.

Meridan's Facility II holds ISO 13485:2016 certification, the quality management system standard specific to the design and manufacture of medical devices. This certification is essential for packaging combination products, medical device ancillaries, and drug-device kits where packaging is considered part of the device manufacturing process. ISO 13485 imposes additional requirements beyond ISO 9001 around design controls, risk management, traceability, and regulatory compliance specific to the medical device industry.

Meridan's Facility IV holds ISO 14001:2015 certification for its environmental management system, demonstrating a structured approach to managing environmental responsibilities, reducing environmental impact, and achieving continual environmental improvement. The certification covers waste management, energy efficiency, emissions control, and sustainable resource use. Meridan has committed to expanding ISO 14001 certification across all three facilities by 2027 as part of its broader environmental, social, and governance strategy.

Meridan holds active DEA registrations at Facilities I and III, authorizing these sites to receive, store, handle, and package controlled substance medications across Schedules II through V. DEA licensure requires stringent physical security measures including vault storage, access-controlled production areas, continuous surveillance systems, and comprehensive chain-of-custody documentation for every unit of controlled substance material from receipt through final shipment. These facilities maintain perpetual inventory controls and are subject to unannounced DEA inspections.

Meridan holds Health Canada site licenses at Facilities I and II, authorizing these locations to package pharmaceutical products destined for the Canadian market. This license requires compliance with Canadian GMP standards as defined in the Food and Drug Regulations (C.R.C., c. 870) and the GUI-0001 guidelines. Health Canada authorization enables Meridan to support customers with North American commercial supply strategies from a single packaging partner, simplifying supply chain logistics and regulatory oversight.

Meridan's Facilities I and II maintain operational alignment with European Union GMP requirements, including relevant provisions of EudraLex Volume 4 and applicable Annex guidelines. While not EU-inspected, these facilities have implemented the serialization, tamper-evidence, and documentation standards necessary to package products intended for EU-destined markets. This capability enables pharmaceutical customers to leverage Meridan as a packaging partner for global supply programs that include European distribution.