ABOUT BioC CONTACT US
ABOUT BioC VISION.
At BioConvergence, our vision is to advance medical products that will improve the lives of those who need better healthcare solutions. We realize that this vision is a team effort, which is why we partner with pharmaceutical and biotechnology companies of all sizes and motivations to develop, deliver, and innovate processes and solutions that make an impact.
Contract Service Provider
CULTURE.
www.bioc.us
Our vested interest in our clients’ success encourages a culture of quality and transparency that is apparent throughout the organization. We support this culture through building collaborative teams that encourage and reward accuracy, agility, and accountability.
QUALITY.
Our quality assurance team is involved in all operational processes and works alongside our laboratory, production, and warehouse staff to ensure perpetual accuracy and proper control in daily operations. BioConvergence is FDA registered and cGMP compliant.
TRANSPARENCY.
At BioConvergence, we believe in being completely transparent with our clients. With our innovative E-Transparency system, clients are able to view their inventory and storage conditions 24/7, and make requests for shipping and receipts. We also offer full access to documentation surrounding BioC’s Standard Operating Procedures.
COMPREHENSIVE SOLUTIONS. We realize that each of our clients has differing needs, depending on product stage, business model, economic factors, and more. As a result, we partner with clients to understand their needs from a holistic perspective, accounting for both current and future considerations. Our four service lines (development, testing, production, and supply chain) complement each other, offering a comprehensive set of solutions to flexibly adapt to clients’ needs throughout the clinical pathway.
CONTACT US 4320 W. Zenith Dr. Bloomington, IN 47404
1.812.961.1700 [email protected] www.bioc.us
TESTING The laboratory team at BioConvergence provides solutions along the drug development pathway of both large and small molecule formations from early stage product characterization and analytical testing to raw material release testing during manufacturing.
• QC Release Testing • Stability Testing (ICH) • Degradation & Impurity Studies • Reconstitution Studies • Non-Clinical Formulation & Fill (GLP) • Method Transfer & Validation • Raw Material Release Testing
BioConvergence helps clients to build a strong portfolio of data early on and throughout the drug development process through a variety of validated ICH stability chambers, TC/TE studies, or transport process design and qualification services.
Two clean rooms held to ISO 8 standards allow for sampling and dispensing of bulk materials.
DEVELOPMENT • Formulation • Lyophilization • Particle Size Reduction • Compatibility Studies • Developmental Formulation & Fill • Method Qualification
PRODUCTION • Label, De-Label, Re-Label • Kit • Package • Time out of Refrigeration Tracking
BioConvergence’s production staff can support clients during pre-clinical studies, clinical trials, blinded studies, mergers and acquisitions with repackaging requirements, and with commercial products.
SUPPLY CHAIN
BioConvergence supply chain operations take place in a 50,000-square-foot, cGMP-compliant warehouse with storage conditions ranging from Room Temperature down to -80°C.
• Distribution • Sampling/Dispensing • Materials Management • Storage •C old Chain Solutions •T ransport Process Design & Qualification
At BioConvergence, our vision is to advance medical products that will improve the lives of those who need better healthcare solutions. We realize that this vision is a team effort, which is why we partner with pharmaceutical and biotechnology companies of all sizes and motivations to develop, deliver, and innovate processes and solutions that make an impact.
Contract Service Provider
CULTURE.
www.bioc.us
Our vested interest in our clients’ success encourages a culture of quality and transparency that is apparent throughout the organization. We support this culture through building collaborative teams that encourage and reward accuracy, agility, and accountability.
QUALITY.
Our quality assurance team is involved in all operational processes and works alongside our laboratory, production, and warehouse staff to ensure perpetual accuracy and proper control in daily operations. BioConvergence is FDA registered and cGMP compliant.
TRANSPARENCY.
At BioConvergence, we believe in being completely transparent with our clients. With our innovative E-Transparency system, clients are able to view their inventory and storage conditions 24/7, and make requests for shipping and receipts. We also offer full access to documentation surrounding BioC’s Standard Operating Procedures.
COMPREHENSIVE SOLUTIONS. We realize that each of our clients has differing needs, depending on product stage, business model, economic factors, and more. As a result, we partner with clients to understand their needs from a holistic perspective, accounting for both current and future considerations. Our four service lines (development, testing, production, and supply chain) complement each other, offering a comprehensive set of solutions to flexibly adapt to clients’ needs throughout the clinical pathway.
CONTACT US 4320 W. Zenith Dr. Bloomington, IN 47404
1.812.961.1700 [email protected] www.bioc.us
TESTING The laboratory team at BioConvergence provides solutions along the drug development pathway of both large and small molecule formations from early stage product characterization and analytical testing to raw material release testing during manufacturing.
• QC Release Testing • Stability Testing (ICH) • Degradation & Impurity Studies • Reconstitution Studies • Non-Clinical Formulation & Fill (GLP) • Method Transfer & Validation • Raw Material Release Testing
BioConvergence helps clients to build a strong portfolio of data early on and throughout the drug development process through a variety of validated ICH stability chambers, TC/TE studies, or transport process design and qualification services.
Two clean rooms held to ISO 8 standards allow for sampling and dispensing of bulk materials.
DEVELOPMENT • Formulation • Lyophilization • Particle Size Reduction • Compatibility Studies • Developmental Formulation & Fill • Method Qualification
PRODUCTION • Label, De-Label, Re-Label • Kit • Package • Time out of Refrigeration Tracking
BioConvergence’s production staff can support clients during pre-clinical studies, clinical trials, blinded studies, mergers and acquisitions with repackaging requirements, and with commercial products.
SUPPLY CHAIN
BioConvergence supply chain operations take place in a 50,000-square-foot, cGMP-compliant warehouse with storage conditions ranging from Room Temperature down to -80°C.
• Distribution • Sampling/Dispensing • Materials Management • Storage •C old Chain Solutions •T ransport Process Design & Qualification
