Strategic Quality Services

Quality Management System Design & Implementation - Developing customized QMS frameworks aligned with ISO 9001, ISO 13485, or industry-specific standards, including documentation architecture, procedure development, and organizational integration strategies.

Regulatory Compliance Consulting - Providing guidance on FDA regulations, EU MDR/IVDR, GMP requirements, and global regulatory frameworks, including gap analysis, remediation planning, and ongoing compliance maintenance.

Risk Management & FMEA Services - Conducting comprehensive risk assessments using methodologies such as Failure Mode Effects Analysis, Hazard Analysis Critical Control Points (HACCP), and ISO 14971 risk management for medical devices.

Supplier Quality Management - Establishing supplier qualification programs, vendor audits, incoming inspection protocols, and supply chain quality assurance frameworks to ensure raw material and component integrity.

Quality Engineering & Statistical Process Control - Implementing advanced statistical methods including Six Sigma, control charting, process capability analysis (Cp/Cpk), and design of experiments (DOE) to optimize manufacturing processes.

Validation & Qualification Services

Process Validation Protocols - Developing and executing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for manufacturing equipment and processes according to FDA guidelines and international standards.

Computer System Validation (CSV) - Validating software systems, laboratory information management systems (LIMS), electronic batch records, and manufacturing execution systems per 21 CFR Part 11 and GAMP 5 guidelines.

Cleaning Validation - Establishing scientifically sound cleaning validation protocols, acceptance criteria determination, analytical method validation, and visual cleanliness assessments for pharmaceutical and medical device manufacturing.

Sterilization Validation - Developing and executing validation protocols for steam, ethylene oxide, radiation, and aseptic processing sterilization methods according to ISO 11135, ISO 11137, and ISO 13408 standards.

Method Validation & Transfer - Validating analytical methods per ICH Q2(R1) guidelines, establishing method equivalency, and facilitating analytical method transfers between laboratories or sites.

Audit & Assessment Services

Internal Audit Programs - Designing and conducting systematic internal audits of quality systems, manufacturing operations, laboratories, and documentation practices with detailed findings and corrective action recommendations.

Pre-Approval Inspection (PAI) Readiness - Preparing organizations for regulatory inspections through mock audits, documentation review, facility assessments, and personnel interview training.

Supplier Audits - Performing on-site and remote audits of raw material suppliers, contract manufacturers, testing laboratories, and service providers using risk-based audit protocols.

Gap Analysis & Benchmarking - Comparing current quality practices against regulatory requirements, industry best practices, and competitor standards to identify improvement opportunities.

Third-Party Certification Audits - Facilitating ISO certification processes including 9001, 14001, 45001, and industry-specific standards through pre-audit assessments and documentation support.

Calibration & Metrology Services

Calibration Program Development - Establishing comprehensive calibration management systems including equipment inventory, calibration frequencies, traceability requirements, and out-of-tolerance investigations.

Measurement System Analysis (MSA) - Conducting Gage R&R studies, bias and linearity assessments, and measurement uncertainty calculations to ensure reliable measurement systems.

Environmental Monitoring Programs - Designing and implementing programs for cleanroom monitoring, temperature mapping, humidity control verification, and compressed gas purity testing.

Equipment Qualification Services - Performing installation, operational, and performance qualifications for laboratory instruments, manufacturing equipment, and environmental control systems.

Inspection & Testing Services

In-Process Inspection Protocols - Developing sampling plans, inspection procedures, and acceptance criteria for raw materials, in-process materials, and finished products using statistical sampling methods.

Final Product Release Testing - Establishing batch release testing protocols, certificate of analysis requirements, and stability testing programs according to ICH guidelines.

Destructive & Non-Destructive Testing - Implementing testing methodologies including tensile testing, compression testing, ultrasonic testing, X-ray inspection, and failure analysis procedures.

Packaging Validation - Conducting package integrity testing, transportation simulation, accelerated aging studies, and environmental conditioning per ASTM standards.

Documentation & SOP Development

Standard Operating Procedure Creation - Writing clear, compliant SOPs for all quality-critical operations including manufacturing, testing, calibration, deviation handling, and change control processes.

Quality Documentation Systems - Developing document control systems, revision management protocols, electronic document management solutions, and training documentation frameworks.

Batch Record Design - Creating manufacturing batch records, laboratory worksheets, and electronic batch record templates that ensure regulatory compliance and operational efficiency.

Investigation & CAPA Systems - Establishing deviation investigation procedures, root cause analysis methodologies, corrective and preventive action systems, and effectiveness verification protocols.

Training & Competency Development

GMP Training Programs - Delivering customized training on current Good Manufacturing Practices, Good Laboratory Practices (GLP), Good Documentation Practices (GDP), and aseptic processing techniques.

Regulatory Affairs Training - Providing education on FDA regulations, international regulatory requirements, submission strategies, and post-market surveillance obligations.

Quality Tools & Techniques - Teaching practical application of Lean, Six Sigma, root cause analysis tools (5 Why, Fishbone diagrams), statistical methods, and continuous improvement methodologies.

Auditor Training & Certification - Developing internal auditor competencies through ISO 19011-based training programs, audit simulation exercises, and lead auditor certification courses.

Technical Skills Development - Offering specialized training in analytical techniques, equipment operation, validation principles, and industry-specific technical competencies.

Industry-Specific Services

Pharmaceutical & Biotechnology - cGMP compliance, drug stability programs, process development support, clinical trial material quality, and combination product strategies.

Medical Device Manufacturing - Design control implementation, biocompatibility testing guidance, human factors validation, post-market surveillance systems, and MDR/IVDR compliance.

Food & Beverage - HACCP plan development, food safety management systems, allergen control programs, sanitation validation, and FSSC 22000 certification support.

Automotive & Aerospace - IATF 16949 and AS9100 compliance, PPAP documentation, advanced product quality planning (APQP), first article inspection (FAI), and traceability systems.

Chemical & Petrochemical - Process safety management, batch consistency programs, environmental compliance integration, and responsible care management systems.

Industry-Specific Services

Pharmaceutical & Biotechnology - cGMP compliance, drug stability programs, process development support, clinical trial material quality, and combination product strategies.

Medical Device Manufacturing - Design control implementation, biocompatibility testing guidance, human factors validation, post-market surveillance systems, and MDR/IVDR compliance.

Food & Beverage - HACCP plan development, food safety management systems, allergen control programs, sanitation validation, and FSSC 22000 certification support.

Automotive & Aerospace - IATF 16949 and AS9100 compliance, PPAP documentation, advanced product quality planning (APQP), first article inspection (FAI), and traceability systems.

Chemical & Petrochemical - Process safety management, batch consistency programs, environmental compliance integration, and responsible care management systems.

Advanced Quality Services

Data Integrity Programs - Implementing ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate plus Complete, Consistent, Enduring, Available), electronic record controls, and audit trail review procedures.

Continuous Process Verification (CPV) - Transitioning from traditional periodic validation to ongoing process monitoring and control using real-time data analytics and statistical process control.

Quality Culture Transformation - Facilitating organizational change management, quality leadership development, cross-functional collaboration improvements, and quality metrics dashboard implementation.

Technology Transfer Services - Managing the transfer of manufacturing processes, analytical methods, and quality systems between development and commercial sites or between contract manufacturers.

Regulatory Intelligence & Strategy - Monitoring global regulatory changes, interpreting new guidance documents, developing regulatory strategies for new markets, and managing regulatory authority interactions.