About Us
P&A is a full-scale life sciences business consultant team specialized in USFDA-related activities for the
Pharmaceutical (Aseptic and Non-septic products), Biotechnology, Combination products (drug and
device) and packaging products industries. We provide expertise in Quality systems, Risk assessment
and mitigation, Compliance and Audits, FDA regulatory matters (483-response analysis for adequacy,
Warning Letters response) and consent decree management.
What does The P&A Consultants do?
Consulting Models:
☛ Quality Management System
☛ Regulatory Affairs
☛ Expert Witness
☛ M&A Due Diligence
☛ Quality Systems & SAP Integration
Our Working models:
☛ Regulatory Inspection Management
☛ 3P Batch Review and Release
☛ HA communications
☛ Legal Help for Compliance and Litigation
☛ Restructuring and Reorganization
☛ Sustainable Quality Solutions
Our Values
Learn how our Core Values can help you achieve extraordinary results.
Our Competitive Edge
Learn what makes us different and what sets us apart.
Corporate social responsibility
Our active and positive social role in the world .
