Biowy CDMO services
Contract Development and Manufacturing Organization
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Design & Development
Whether you are in the early stages of product design or seeking to develop a concept, we are here to assist you. Our team will conduct comprehensive research, design, and development tailored to your needs. From part sourcing and material preparation to formulation development, we provide end-to-end support throughout the process
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Quality Management & Regulatory Affairs
Ensuring effective quality control is critical for a thriving business. Our dedicated quality control team is committed to ensuring your product meets the highest standards, exceeding customer expectations. Additionally, we offer support in implementing a Quality Management System (QMS) in accordance with ISO 13485 and assist with all regulatory compliance, including FDA 510(k) requirements
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Manufacturing
Our manufacturing facility features an ISO Class 7 cleanroom, complemented by an adjacent warehouse. We manage the entire production process, including material sourcing, assembly, packaging, sterilization, shipping, and inventory control. Whether your business requires a comprehensive solution or specific services, we offer the flexibility to meet your unique needs.
Design/Development
From a napkin sketch to implementing further research, our team of scientists will research, design, and develop your product. Our dual lab spaces feature state of the art technology like:
Hettich Centrifuge
Shimadzu FTIR
Shimadzu UV spectrophotometer
Shimadzu spectro fluorophotometer
Shimadzu HPLC
Hydraulic burst leak tester
Nidec force gauge
Quality Management/Regulatory Affairs
Every successful business starts with quality products. We are here to fill that need by offering our team of quality experts. From quality management system design to regulatory affairs certifications and quality control, we will help your business for every quality need.
Manufacturing
Our ISO-7 clean room manufacturing facilities allow you to have the peace of mind knowing professionals are manufacturing your product. Our team will handle material sourcing, assembly, packaging, sterilization, inventory control, and shipping.
With over 10,000 square feet of warehouse space, our facility has ample space to fulfill the largest orders.
