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With over 40 years of cGMP manufacturing experience, Ferro Pfanstiehl has firmly in place the documentation, validation, and qualification systems to assure compliance with the FDA and other regulatory bodies worldwide. Maintaining more than 20 Drug Master Files (DMF's) for customers and for Ferro Pfanstiehl proprietary drug products, our services include cGMP manufacturing, and cGMP-compliant process development and validation.
cGMP Expertise
- FDA registered and inspected facilities
- More than 20 active DMF's: U.S. Type II, Canadian, and European DMF's and Certificates of Suitability (plus many more, inactive)
- Fully qualified equipment and utilities in cGMP manufacturing areas
- cGMP development and scale-up services
- Experienced development, manufacturing, quality assurance and regulatory affairs teams
Our Quality Assurance and Regulatory Affairs team includes individuals dedicated full-time to equipment and process validation, document control, training, maintenance, and SOPs. From processing of kilogram quantities for Phase I clinical trials to ton-scale commercial production, this team is there to oversee the development of process and validation protocols, to establish and maintain Drug Master Files and to assure that FDA-compliant manufacturing protocols are followed.
For more information, contact us or call 1-800-383-0126.
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