Quality, Manufacturing & Operations Excellence

QMS Implementation & Improvement

Design, implementation, and enhancement of Quality Management Systems (QMS) in line with ISO 13485, EU GMP, ICH Q10, and 21 CFR Part 820. Support includes:

• Quality manual and SOP development

• Document control and change management

• CAPA systems and deviation management

• Training systems and ongoing compliance monitoring

Internal & External Audits

Preparation, execution, and follow-up for regulatory and third-party inspections (e.g., FDA, EMA, Notified Bodies), including:

• Audit readiness assessments

• Mock audits and gap analyses

• Support during inspections

• CAPA development and remediation execution

Training & Competency Management

Tailored training programs to ensure organizational readiness and compliance. This includes:

• GxP training for operations, quality, and management staff

• Role-based training matrices and records

• Competency assessment systems

• Ongoing training effectiveness evaluations

Lean Programs & Six Sigma Expertise

Lean improvement programs designed and delivered by in-house Lean Six Sigma Black Belts, including:

• Lean process mapping and waste reduction

• Yellow, Green, and Black Belt training & certification

• Continuous improvement strategies and cultural integration

Pharmaceutical Production & Quality Leadership

Hands-on support from experienced manufacturing and quality professionals for:

• Batch release and QA oversight

• Production scale-up and tech transfer

• cGMP compliance in aseptic and non-aseptic environments

• Quality oversight of contract manufacturers

Qualification & Validation Services

Comprehensive validation lifecycle services for GxP systems and facilities, including:

• Equipment qualification: IQ/OQ/PQ

• Cleaning validation and process validation

• Method and packaging validation

• Computer System Validation (CSV)

• Facility and utility qualification