Precision-Driven
Remediation Projects
Ensuring accuracy, transparency, and
compliance.
Non-Compliance Remediation & Action Plans
Develop an action plan for responding to statements of non-compliance, including warning letters and FDA Form 483s. Incorporating our practical remediation solutions into your overall quality system for long-term, sustainable compliance.
In an uncertain world, PQP’s remediation expertise helps companies around the globe achieve compliance with optimised, pragmatic and risk-based solutions.
Our team of pharmaceutical consultants includes industry experts to help companies develop strategic plans to address enforcement actions from the FDA, MHRA, EMA and other global authorities.
Respond to adverse regulatory inspection findings, build a compliant quality system or implement a remediation plan to prevent problems in the future. We work with you to build a quality system that is sustainable for your business.
Receive a risk-based gap assessment, corrective action plans and ongoing implementation support. We also provide ongoing coaching and mentoring for team members at all levels to ensure your culture changes in a sustainable way.
Systems-Based Compliance Audits
We use a systems-based approach to compliance and cover all major pharmaceutical subsystems, including:
Quality systems
Laboratories
Material controls
Facilities and utilities
Production
Packaging and labelling
Do you need support or consultation?
Insights, Announcements & Events
Strengthening Quality Systems in a Rapidly Evolving Life Sciences Landscape
Why Risk Mitigation is Becoming a Top Priority in Pharma and Biotech
The Growing Importance
of Compliance Readiness in Cell & Gene Therapy
Quality System
Remediation: A Rising Need After Regulatory Findings
Strengthening Quality Systems in a Rapidly Evolving Life Sciences Landscape
Strengthening Quality Systems in a Rapidly Evolving Life Sciences Landscape
Helpful Answers to
Common Queries
We work with a wide range of life science organizations, including pharmaceutical manufacturers, biotechnology companies, and cell & gene therapy (CGT) developers. Our expertise also extends to contract development and manufacturing organizations (CDMOs), medical technology firms, and early-stage startups that need to establish strong quality foundations. Whether you are scaling operations, preparing for regulatory inspections, or remediating quality system gaps, we provide tailored support to meet your specific needs.
We work with a wide range of life science organizations, including pharmaceutical manufacturers, biotechnology companies, and cell & gene therapy (CGT) developers. Our expertise also extends to contract development and manufacturing organizations (CDMOs), medical technology firms, and early-stage startups that need to establish strong quality foundations. Whether you are scaling operations, preparing for regulatory inspections, or remediating quality system gaps, we provide tailored support to meet your specific needs.
We work with a wide range of life science organizations, including pharmaceutical manufacturers, biotechnology companies, and cell & gene therapy (CGT) developers. Our expertise also extends to contract development and manufacturing organizations (CDMOs), medical technology firms, and early-stage startups that need to establish strong quality foundations. Whether you are scaling operations, preparing for regulatory inspections, or remediating quality system gaps, we provide tailored support to meet your specific needs.
We work with a wide range of life science organizations, including pharmaceutical manufacturers, biotechnology companies, and cell & gene therapy (CGT) developers. Our expertise also extends to contract development and manufacturing organizations (CDMOs), medical technology firms, and early-stage startups that need to establish strong quality foundations. Whether you are scaling operations, preparing for regulatory inspections, or remediating quality system gaps, we provide tailored support to meet your specific needs.
We work with a wide range of life science organizations, including pharmaceutical manufacturers, biotechnology companies, and cell & gene therapy (CGT) developers. Our expertise also extends to contract development and manufacturing organizations (CDMOs), medical technology firms, and early-stage startups that need to establish strong quality foundations. Whether you are scaling operations, preparing for regulatory inspections, or remediating quality system gaps, we provide tailored support to meet your specific needs.
We work with a wide range of life science organizations, including pharmaceutical manufacturers, biotechnology companies, and cell & gene therapy (CGT) developers. Our expertise also extends to contract development and manufacturing organizations (CDMOs), medical technology firms, and early-stage startups that need to establish strong quality foundations. Whether you are scaling operations, preparing for regulatory inspections, or remediating quality system gaps, we provide tailored support to meet your specific needs.
