About Kyro BioPharma 

GAP Analysis: Identify deficiencies in existing quality systems relative to FDA, EMA, and global regulatory standards.

System Upgrades & End-to-End Remediation: Implement corrective actions, process improvements, and documentation updates to achieve and sustain compliance.

Inspection Readiness: Prepare organizations for regulatory inspections and audits.

Design & Optimization: Develop and refine manufacturing and laboratory processes for efficiency, scalability, and compliance.

Troubleshooting: Address process deviations, bottlenecks, and yield issues.

Tech Transfer: Support the transfer of processes from R&D to commercial production.

Implementation: Deploy and configure Manufacturing Execution Systems (MES) to manage production workflows.

System Integration: Ensure seamless connectivity between MES, ERP, and lab systems.

Support & Maintenance: Provide ongoing system optimization and troubleshooting.

Production Leadership: Oversee daily manufacturing operations, resource planning, and KPI tracking.

Continuous Improvement: Implement Lean, Six Sigma, and operational excellence initiatives.

Supply Chain Coordination: Manage procurement, inventory, and logistics.

Test Protocol Development: Author and execute test plans for equipment and systems.

Validation Oversight: Ensure systems meet user and regulatory requirements before commissioning.

System Design: Engineer new or upgrade existing mechanical, electrical, and software systems for manufacturing and laboratory environments.

Troubleshooting & Maintenance: Provide rapid response to system failures and support preventive maintenance.

Process Development: Optimize production methods and scale-up processes.

Technical Transfer: Facilitate the transfer of products and processes between sites or from development to manufacturing.

Process Support: Resolve technical issues during manufacturing.

Batch Record Review: Ensure all production and testing documentation meets regulatory standards.

SOP & Technical Writing: Develop and maintain standard operating procedures and technical documents.

Analytical Testing: Conduct and oversee laboratory testing for product release and stability.

Deviation & CAPA Management: Investigate non-conformances and implement corrective actions.

Validation: Develop and execute validation protocols for freeze-drying processes.

QMS Support: Integrate lyophilization into existing quality management systems.

Document Management: Oversee creation, revision, approval, and archiving of controlled documents.

Records Retention: Ensure compliance with regulatory requirements for documentation.

Staffing for Compliance and Accuracy:
Kyro BioPharma Solutions supplies Document Control Specialists, QA Documentation Coordinators, and Validation Support Analysts who manage, review, and archive GMP and cGMP documentation. Our consultants ensure every SOP, batch record, and validation report is properly authored, approved, and version-controlled to meet FDA and ISO 13485 standards.

Kyro BioPharma Solutions (KBPS) provides Commissioning, Qualification, and Validation (CQV) support to pharmaceutical and biotech companies by deploying experienced consultants who ensure GMP systems, facilities, and processes meet FDA and industry standards.

KBPS supplies complete CQV project teams or individual specialists for startups, expansions, and remediation efforts. Roles include CQV Engineers, Validation Specialists, Commissioning Engineers, Process Engineers, CSV (Computer System Validation) Engineers, Quality Engineers, Project Managers, and Validation Managers. 

Compliance Assurance: Validate software and automated systems to meet 21 CFR Part 11 and other regulatory standards.

System Auditing: Perform periodic reviews and revalidations.

Kyro BioPharma Solutions provides Computer System Validation Engineers, IT QA Specialists, and CSV Project Leads who ensure all software, automation, and data systems used in GMP environments comply with FDA 21 CFR Part 11, GAMP 5, and Annex 11 requirements. Our experts handle validation planning, risk assessments, protocol writing (IQ/OQ/PQ), and testing for systems like LIMS, MES, ERP, and process automation platforms.

Clean Room & Facility Design: Plan, build, and qualify GMP-compliant manufacturing and laboratory spaces.

Project Oversight: Manage timelines, budgets, and contractor coordination.

Equipment Qualification: Lead FAT/SAT for fill-finish lines, packaging, and injector assembly.

Process Optimization: Enhance throughput and reliability of final dosage form production.

Engineering & Validation: Design, install, and qualify HVAC, water systems, and process equipment.

Maintenance Programs: Develop preventive maintenance and calibration schedules.

Platform Expertise: Configure and support Delta V, Rockwell, Siemens, and PLC-based systems.

Integration: Connect automation systems with MES, LIMS, and ERP platforms.

Program Development: Establish and maintain environmental monitoring programs for clean rooms and controlled environments.

Data Analysis: Interpret trends and respond to excursions.

Filing & Submissions: Prepare IND, NDA, ANDA, BLA, and CE Mark submissions.

Global Compliance: Advise on international regulatory requirements and market entry.

Safety Monitoring: Implement and manage adverse event reporting systems.

Regulatory Documentation: Prepare biocompatibility assessments and safety dossiers.

Internal/External Audits: Conduct GMP, GLP, and GCP audits.

Post-Market Surveillance: Monitor product safety and performance in the market.

Inspection Support: Provide guidance during regulatory inspections.