Ensuring accuracy, transparency, and
compliance.
GxP Deficiency Resolution & Regulatory Support
Obtain timely pragmatic solutions for your GxP findings and develop effective next steps to meet regulatory requirements and expectations. PQP provides quick and proportionate response services for GxP deficiencies by identifying root causes and determining effective corrective and preventive actions (CAPAs) to help you avoid costly recurring deficiencies.
We support organisations through risk assessments, product quality evaluations and detailed root cause analysis. In addition to helping our clients revise existing policies, we support the design of new policies, procedures and records. We also ensure sustainable improvements by coaching individual behaviour and supporting changes in team culture.
Fix regulatory issues for the long-term and avoid similar issues in the future through our coaching and mentoring services and simplification projects. Our coaching and mentoring services support effective corrections, corrective actions and preventive actions with sound effectiveness checks.
We also respond to all types of regulatory communications, assist in regulatory meetings and act as expert witnesses or subject matter experts.
FDA responses
EMA responses
Regulatory agency meeting preparation
Action plan development
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.
