Clinical Supplies

Biosphere Sourcing provides unrivalled global access to medicines and ancillaries for use in clinical trials and drug development research.  Whether it be for use as a comparator, co-med, rescue therapy or ancillary supply, our global network of manufacturers and authorized distributors, underpinned by our market-leading Quality Management System, enables us to provide a customized end-to-end supply solution for our clients.  This ethical approach to supply ensures we can deliver a sustainable and reliable supply solution for sponsors, healthcare professionals and patients globally.      

Our established processes ensure we can access the most challenging / restricted products for clinical trials and drug development, whilst operating to the highest standards of governance, quality and customer service.

Quality is at the core of what we do and how we operate. Our in-house Quality & Regulatory team work to support all of our client partnerships throughout the journey of their product development.

• Comparator products
• Reference Listed Drugs (RLD)
• Biologics
• Specialty products (REMS)
• Orphan Drugs
• Patient access-only products

Our Strengths:

• Knowledge and understanding to manage every aspect of pharmaceutical and biopharmaceutical shipments including special requirements for cold chain shipments, biologics, hazardous materials and controlled substances
• Years of practical experience in sourcing and shipping throughout North America, Europe, South America, and Southeast Asia
• Ability to source single or multiple lots, innovator and generic equivalents and lots with the longest expiration dates
• Adherence to Current Good Manufacturing Practices (CGMP), Good Clinical Practices (GCP), International Conference on Harmonization (ICH) guidelines and industry best-practices
• Complete confidentiality for all our clients
• Supporting documentation including pro-forma invoices, MSDSs, Certificates of Analysis (when available), package inserts and product specifications

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