VolPal
Our Experience
Project setup and design of large scale compliance remediation program for 100s of products after FDA 483.
Remediation Program
Compliant QbD program for product development.
Training
Program to validate a new process/facility ensuring compliance to FDA 2011 guidance.
Validation
Incorporation of risk management into Quality System.
Strategy
Preparation for FDA inspection.
Readiness
Gap analysis and remediation plan.
Gap Analysis
Project management of large change program to improve Quality System and make all needed changes in 12 month period.
Program Management
Management of complex multi-site transfer using risk prioritization and project management to deliver to promise.
Tech Transfer
Scale up of large project by delivering the right resources at the right price at the right time.
Skilled Resources
Use of Project Management to design cost effective project with proper planning to accurately predict schedule and cost.
Compliance Program
Statistical expertise combined with ex-FDA specialists to defend product in market.
Product Defense
Strategy and support in forming response to warning letter with planning of what are realistic timelines to mitigate.
Warning Letter Response
Redesign of Quality System ad procedures to be aligned with modern FDA thinking. Workable Quality System.
Quality System
Global reach and experience – managing and staffing projects.
Overseas
Support with FDA interaction and communication.
FDA