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Contract Manufacturing

Leader Biomedical’s contract manufacturing operations (CMO and OEM) is an ISO 9001:2015 and ISO 13485:2016 certified company that understands the importance of implementing and maintaining the highest standards in business, quality and manufacturing practices.

EMCM possesses a Good Manufacturing Practice Licence for the manufacturing of Pharmaceuticals and a Tissue Licence for the storing, processing and distribution of human tissue. We are subject to several national, European and international inspections in order to maintain our certifications to manufacture products for global markets. EMCM is a GMP Licensed organisation, processing a broad range of healthcare products for the pharmaceutical, medical device, and tissue sectors of the healthcare industry and has been successfully inspected by the USFDA, ANVISA, and other European authorities for providing products to the global markets. According to standard procedures, EMCM performs validation and/or verification of processes, qualification of equipment, utilities, and analytical methods. Furthermore, all critical processes for manufacturing biomaterials and pharmaceuticals are validated.

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Liquids, Suspensions, Gels

Leader Biomedical Group’s contract manufacturing operations (CMO) deliver a wide variety of biomedical products ranging from volatile liquids, high viscous suspensions, and gels for orthopaedic, dental, medical aesthetic, and niche pharmaceutical applications.
Our facilities are able to support manufacturing operations for ampoules, vials, pre-filled syringes, pouches, bottles, and blisters. We are experts in bringing your innovations to the market, showing a high degree of flexibility to meet your needs. We host a variety of in-house technologies, retain highly professional key personnel, and have a well-equipped Dutch based facility with over 1,500 square meters of GMP accredited classified areas, conforming to FDA, ISO & GMP standards for the manufacturing of medical products.

We possess a range of (semi-) automatic filling units for the filling of organic solvents, aqueous solutions, gels, and suspensions. All filling processes can be performed under aseptic conditions and will be validated by media simulations according GMP and ISO requirements. The formulation of all liquids, gels, and suspension can be executed under class A/B aseptic condition before filling in the required primary packaging.

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Powders

The Leader Biomedical Group possesses medium scale powder mixers, including a range of sieving devices, to mix powder components, and to guarantee a homogenous bulk product.

Semi-automatic equipment is used, which are operated by qualified operators and controlled by product specific qualification and validation programs. We are also equipped with a range of (semi-) automatic filling units to fill powder into vials, pouches, and small containers.