Your needs for assurance and superior quality for customized specifications are achieved with constant and diligent compliance to global regulatory requirements. SAFC Biosciences creates, manages and provides comprehensive documentation packages to support your specification development and regulatory submission needs.
Regulatory Compliance
We continuously monitor international regulatory directives and trends to ensure compliance with relevant guidelines. We collaborate with you in understanding regulations to continuously improve our quality systems and validation processes.
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Our dedicated regulatory support experts ensure compliance with all relevant regulatory bodies |
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Key practices are in place to minimize risks associated with animal-origin components |
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We support your regulatory submissions by supplying specific information through a Drug Master File (DMF), Certificate of Suitability (COS), Component Source
Summary (CSS). We can also provide assistance with the Chemistry and
Manufacturing Control (CMC) sections of your IND or INAD applications. |
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Quality Management
We know how important and urgent quality management is to you. Our single, company-wide Quality Management System is specific to the stringent requirements of the biopharmaceutical manufacturing industry. With SAFC Biosciences, your compliance audits and technical inquiries are fully supported by expert project teams.
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The SAFC Biosciences Quality Policy states we will comply with the requirements of the current version of the ISO 9001 Quality Management System and shall be
continually and systematically renewed for effectiveness and improvement |
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We have an established track record of hosting more than 70 audits annually by biopharmaceutical organizations resulting in subsequent qualification |
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Our dedicated technical compliance staff validates design and implementation of our manufacturing processes and critical operating parameters |
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The process of establishing product specifications, to identify and develop the most characterized and consistent raw materials, is overseen by our dedicated quality
management staff |
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Stability programs are in place for key components and products |
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We quickly and openly respond to technical troubleshooting, quality-related inquiries and requests for documentation to provide resolution and execute corrective and
preventative action as required |
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Change Management
Changes to materials and processes must carefully and proactively be managed so there is no impact on established performance characteristics.
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You are informed in advance, typically 90 days, of proposed changes to process and product specifications, consistent with our global change control process |
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Our vendor management program assures that our suppliers are held to the same change management standards to which you hold us |
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Have a question or just curious?
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