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Regulatory Expertise

Regulatory Expertise

CGMP Regulatory Expertise

Medical Products Laboratories, Inc. (MPL) is a leading pharmaceutical contract manufacturing and packaging company which provides an array of services to its customers. MPL has established an excellent reputation as a leading regulatory service provider to the pharmaceutical industry. FDA guidance is a moving target, and our team can turn these complexities into a practical, economical, and manageable experience. From the initial development of a formulation through scale-up of the pilot and commercial phases, MPL's regulatory and compliance teams will help you navigate the current regulations. We continue to dedicate significant resources to monitoring the constantly changing FDA guidelines in order to help our clients understand the regulations relevant to their products.

MPL develops and commercializes products for a number of industries. As a leading pharmaceutical contract manufacturing and packaging company, MPL specializes in the production of human drug products including ANDAs, Schedule IV controlled substances, prescription (Rx), OTC, and homeopathic products, as well as animal drug products including ANADA, prescription, and OTC products. We also produce combination Drug-Devices and C1/C2 Medical Devices, as well as nutraceuticals and various dietary supplements. Due to the wide spectrum of products produced in its facility, MPL operates its business under the drug-world umbrella to ensure the highest level of Quality Control and GXP compliance. We use the drug standard as our guide for all aspects of the development, pilot, and commercial phases along with providing the necessary support for regulatory assistance. The pharmaceuticals MPL produces meet cGXP compliance standards, and our quality management systems have adopted the principles of ISO 9000 and 13485.

MPL can support approved products with either full service or various levels of assistance in filing ANDA, ANADA, and 510(k)s, as well as in managing drug listings for numerous Rx and OTC products. We work with a network of ETCD vendors and CROs as well as our in-house Quality Control teams to design and execute clinical studies and submit the results through the electronic gateway.

CGMP Regulatory Expertise