|
Spectrum has more than 40 years of custom synthesis experience
as a chemistry outsourcing partner to the pharmaceutical and
biotechnology industries. We provide a full range of contract
research and manufacturing services, including the custom
synthesis of new chemical entities (NCE’s) through
commercial cGMP manufacture of active pharmaceutical
ingredients (API’s), DEA Controlled Substances (Schedules
I-V) and their chemical intermediates. Our highly qualified
staff of Ph.D. chemists will follow your project in our
facilities from discovery through
commercialization, providing an unparalleled level of service
throughout the R&D, scale-up and manufacturing process.
• Custom Synthesis of NCE’s • Rapid
Scale-Up of Discovery Leads • Multi-Step Synthetic
Routes • Controlled Substances Manufacture (DEA
Schedules I-V) • Chemical Process Development
• Process Validation • cGMP Manufacture of
Clinical Trial Materials • cGMP Manufacture of
Commercial API’s • Technology Transfer
• Analytical Method Development and Validation
• Customer Audit Support • Customized Packaging
Spectrum Custom Synthesis offers our customers a unique
experience, combining the personalized service and
responsiveness of a mid-size company with the resources,
logistics, and technical depth of much larger companies.
|
 |
|
Spectrum Custom Synthesis has in place the documentation,
validation, and qualification systems to ensure compliance with
the FDA, DEA, ICH, WHO and other worldwide regulatory entities.
Our expertly trained Quality Assurance and Regulatory Affairs
team works closely with our customers to navigate the regulatory
maze associated with compliance to worldwide cGMP standards,
securing quotas for controlled substances, regulatory filings,
and audits.
Spectrum Custom Synthesis fiercely protects the confidentiality
and security of Intellectual Property (IP)
and Technology Transfer Agreements, whether provided by our
customer or developed by our Scientists.
• FDA Registered and Inspected Facilities •
Excellent FDA Inspection History • Qualified
Equipment and Utilities • Sample, Test and Control
Protocols for Raw Materials • ICH Stability
Studies • Submission and Maintenance of DMF
Files • Support with CMC Documentation •
Support for IND, NDA and ANDA Filings • Full-Time
Regulatory Affairs Support • Permits & Quotas
for Controlled Substances • cGMP Compliant SOP’s
• Full Protection for IP and
Technology Transfers
| |