Regulatory Compliance

• NDA Documentation
• NDA Filings & Post Approval Changes
• PAI Readiness
• CMC Sections

Quality Audit

• Suppliers & Third-Party Audits
• Internal Audit Program Support
• GMP & ISO Inspections
• Compliance Gap Assessments
• Audit Management
• Annual Products Reports

Validation

• Equipment and Facilities Qualifications
• Process & Cleaning Validations
• Technology Transfer
• Test Method Validations
• Automation
• Commissioning & Decommission

Technical Training

• Certification Programs
• Technical Trainings
• Soft Skills Trainings
• Professional Development Plans
• Mentoring and Profesional Coaching

Remedation Plans

• Risk Management Assesments
• FDA Compliance Remediation Projects
• Process/Business Improvements
• Project Management
• Lean Six Sigma Improvements Projects

QUALITY ASSURANCE & QUALITY SYSTEMS

• Document Management
• CAPA, Complaints & Investigation
• Quality System Support
• Procedure Design and Revision
• Batch Records Review
• Key Indicator Metrics

EHS

• OSHA Support
• HAZMAT
• Pest Control Programs
• SDS
• Personal Protection Program Support

Technical & Practical Training

• On-Site and Off-Site Training
• Technical Training
• On the Job Training
• Train the Trainers Certifications
• New Hire Trainings

Data Integrity

• Document Management & Control
• Data Systems Security
• Computer System Validations
• GMP Records
• Lifecycle Document Support

Project Management

• Projects Administration
• Project Design, Scheduling, and Implementation
• Project Risk Assessments
• Project and Staffing Support
• Certified PM’s Resources

Human Resources

• Consulting Services HR process
• Organizational Culture Transformation
• Temporary and Permanent Staffing support
• Labor Law Training
• Human Resources processes gap Assessment