REGULATORY COMPLIANCE & QUALITY ASSURANCE
Regulatory Compliance & Quality Assurance
Committed to regulatory excellence, Mumbai Biocluster provides end-to-end regulatory compliance and quality assurance services. Their team ensures that every product adheres to local and international regulations, safeguarding approval pathways and market readiness.
Our Services Includes
01
Regulatory CMC Documentation and Submission Support
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Preparation and submission of regulatory documents, including Chemistry, Manufacturing, and Controls (CMC) sections for INDs, BLAs, NDAs, and MAAs.
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This service ensures that all documentation meets regulatory expectations, is properly formatted, and contains comprehensive data to support regulatory approval.
02
QMS Implementation
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Implementation and maintenance of robust Quality Management Systems (QMS) that align with regulatory requirements.
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Establishment of standard operating procedures (SOPs), managing deviations, conducting risk assessments, and implementing corrective and preventive actions (CAPAs) to maintain the highest standards of quality and compliance.
03
FDA Query Response and Regulatory Compliance
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FDA Query Response Management
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Regulatory Strategy Development
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Regulatory Submission Support
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Quality System Audits and Remediation
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Regulatory Training and Education
04
GMP Auditing and Consulting
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Comprehensive Good Manufacturing Practice (GMP) compliance audits to prepare biotechnology companies for regulatory inspections by agencies like the FDA, EMA, and other global regulatory bodies.
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These audits cover all aspects of manufacturing, quality control, and facility operations to ensure full compliance with regulatory standards.