| REGULATORY AND COMPLIANCE STRATEGY
|
Drugs & APIs
|
Medical Devices
|
Biologics
|
Cosmetics
|
| Pre and Post FDA Inspection Support and Counseling
|
|
|
|
|
| FD-483 and
Warning Letter Responses
|
|
|
|
|
| Corrective
Action / Remediation Plans
|
|
|
|
|
| Medical Device
Submissions
|
|
|
|
|
| Review of
Chemistry/Manufacturing Controls
|
|
|
|
|
| |
|
|
|
|
| 21
CFR COMPLIANCE SERVICES
|
Drugs & APIs
|
Medical Devices
|
Biologics
|
Cosmetics
|
| Part 11 GAP
Analysis
|
|
|
|
|
| Part 11 GAP
Remediation and Compliance Planning
|
|
|
|
|
| Development of
Software QA Programs
|
|
|
|
|
| |
|
|
|
|
| AUDITING & GAP ANALYSIS
|
Drugs & APIs
|
Medical Devices
|
Biologics
|
Cosmetics
|
| Quality
System/GMP Audits
|
|
|
|
|
| GLP Audits
|
|
|
|
|
| PAI Audits
|
|
|
|
|
| Targeted Gap
Analysis: Focus on Specific GMP/QS Requirements
|
|
|
|
|
| |
|
|
|
|
| TRAINING
|
Drugs & APIs
|
Medical Devices
|
Biologics
|
Cosmetics
|
| Quality System
, GMP, GLP, Software, Part 11, and Related Topics
|
|
|
|
|
| Customized Curriculum Development for Client's SOPs/Processes
|
|
|
|
|
| VALIDATION SERVICES
|
Drugs & APIs
|
Medical Devices
|
Biologics
|
Cosmetics
|
| Master
Validation Planning
|
|
|
|
|
| Validation
Program Development
|
|
|
|
|
| Development
and Execution of Protocols for Utilities and Equipment Qualification
|
|
|
|
|
| Process
Validation Support
|
|
|
|
|
| Computer
System and Process Control Software Validation
|
|
|
|
|
| |
|
|
|
|
| QUALITY SYSTEMS- DOCUMENTATION
|
Drugs & APIs
|
Medical Devices
|
Biologics
|
Cosmetics
|
| Quality System
and SOP Development
|
|
|
|
|
| Risk Analysis
Program Development
|
|
|
|
|
| CAPA Program
Development
|
|
|
|
|
| Process
Mapping and SOP Development
|
|
|
|
|
| |
|
|
|
|
| PRODUCT DEVELOPMENT
|
Drugs & APIs
|
Medical Devices
|
Biologics
|
Cosmetics
|
| Conducting
preliminary literature searches,writing design
plans
|
|
|
|
|
| Design Control
Program Development
|
|
|
|
|
| Writing Design
Plans
|
|
|
|
|
| Developing Or
Auditing Design Verification And Design Validation Protocols
|
|
|
|
|
| Assisting In
The Management Of Design Transfer
|
|
|
|
|
| Participating
In Design Reviews As An Independent Observer
|
|
|
|
|
