How we do it

manufacturing

Manufacturing

Through our global network we are able to provide our customers with a safe and effective delivery model. FDA cGMP facilities, procured and packaged in an FDA cGMP packaging facility, and our quality team assures that our manufacturing practices are always current to meet quality standards globally.

Our products are manufactured with the highest quality standards. Our manufacturing takes place in state of the art facilities with advance technology capabilities, and lean manufacturing protocols. Our facilities are cGMP and have regulatory approvals by the United States of America (FDA), United Kingdom (MHRA), Brazil (ANVISA), World Health Organization (WHO), and Canada (TPD). Our team of experts have regulatory backgrounds and understand the basic principles of being compliant with the US FDA and other global regulatory bodies. We continue to implement continuous improvement processes in all of our manufacturing steps, as we understand the importance of delivering effective, safe, and quality product from a trusted source.

Supply Chain & Customer Service

We deliver products that cover a variety of therapeutic areas and dosage forms. Our products range from biologics, pharmaceuticals and legacy over the counter (OTC) products. Biomes supply chain operations include warehousing, storage, fulfillment, transportation management, temperature regulated environments including cold chain, reverse logistics and regulatory compliant disposition. Our Supply Chain is licensed to meet cGMP, FDA, DEA, DOT, VAWD and Federal, State and Regulatory Agency requirements for handling Over-The-Counter, Prescription and Controlled Substances (CII-CV) pharmaceutical products.

Delivery of products is tracked and traced by a technology platform to make certain that product delivery is on time. We have a COMPLIANCE ASSURED delivery system that meet specific standards of the Federal Drug Supply Chain Security Act (DSCSA). Biomes has partnered with Trace link to provide services for our DSCSA solutions.

We provide exceptional service for our customers and we pay attention to their needs. Our goal is to fulfill their passions, and not just their supply lines. We provide quality products by way of a delivery system that gives each customer the confidence and assurance of a well sustained and compliant logistical model. We are able to offer multiple packaging options in a state of the art facility that creates flexibility catered to each customer, physician messaging, exceptional customer service, and patient assistance programs.

Reductions in medication errors and consumer safety are enhanced with our customer services program, label and packaging features, procedures and policies.

People

James Dyson is quoted as saying, “Manufacturing is more than just putting parts together. It's coming up with ideas, testing principles and perfecting the engineering, as well as final assembly.” In other words it is about people. At the people at Biomes are recognized leaders in their respective fields. It is their experience and expertise that ultimately makes the difference between Biomes and our competitors.