Pharma & Bio-Tech
We provide services to pharmaceuticals, medical device, compounding centers, pharmacies and healthcare organizations.
VALIDATION, QUALIFICATION & QUALITY ASSURANCE SUPPORT
- Assessment on applicable Food and Drug Administration Codes and guidance for Pharmaceutical, Medical Devices, Pharmacies and Compounding Centers (FDA and USP)
- Computer Systems Validation (21 CFR Part 11)
- Qualification of: Facilities, Utilities, Equipment
- Cleaning Validation
- SOP generation or verification
- Risk Management, CAPA Program
- Temperature and Humidity mapping
- Cold Chain evaluation and remediation
- Suppliers Audit and evaluation
- Support clients applying corporate guidelines: Gap analysis, Implementation of changes, solutions.
- Project Management
ENGINEERING & FACILITIES SUPPORT
- Clean room design, construction, qualification and certifications
- Upgrades
- Facilities and utilities projects management
- Construction, fences, aluminum security windows and doors, security bars
- Security access mechanism
Trainings
- Technical Writing
- CFR Part 210 and 211
- Good Documentation Practices
- Good Manufacturing Practices
- Good Laboratory Practices
- Good Distribution and Storage Practices
- Validation and Qualification
- Hipaa Law
AUTOMATION
- Design applications to each clients needs
- We make technology to work around your needs.
- Human error reduction through automation
- Get status texts, emails. Check temperature, and/or
- humidity remotely.
- Get to: Monitor, Control, Adjust, Access,
- Acknowledge from your desk, mobile phone or a tablet.
HEALTH CARE COMPLIANCE
- Compliance evaluation
- HCCA trained and Certified as Health Care Compliances Consultant – IP
- Application of the 7 steps for compliance provided by the OIG.