Located in Bloomington, Indiana, BioConvergence is a women-owned business with over 150 years of experience in pharmaceuticals and is dedicated to providing best-in-class outsourcing services. Our scientific expertise and substantial development experience, along with our quality-by-design strategy, contribute to the development of safe, effective, and stable products meeting regulatory requirements.Biopharmaceutical Techniques Supported
Parenteral Product Development:
cGMP Materials Management:
BioConvergence partners with biotech and pharmaceutical companies worldwide to create solutions to meet their growing demands for formulation and analytical development. We utilize our electronic laboratory notebook (ELN) system and enterprise resource planning (ERP) system to allow our clients real time access to their information and data.
Products and Services
BioConvergence offers contract services, including: Parenteral Product Development (lyophilized formulations, solutions, suspensions, and emulsions for both small and large molecules; formulating and processing molecules that are unstable in solution); cGMP Materials Management (services for API, intermediates, raw materials, packaging components, delivery devices and product; validated environmental chambers range from –80 °C to 25 °C for storage at frozen, refrigerated, and controlled room temperature conditions; validated 21 CFR Part 11 compliant ERP system which tracks all inventory transactions); Consulting Services (clients utilize our experienced quality auditors with experience in conducting regulatory inspections by the FDA, EMEA, MHRA and Health Canada).
BioConvergence's new 50,000-sq. ft. facility houses a state-of-the-art 30,000-sq. ft. cGMP warehouse and 2,500-sq. ft. cGLP laboratory that is designed for the needs of our clients. Our lab offers capabilities for lyophilization and other analytical procedures for product development, clinical and commercial phases.