Receive an expert assessment of your resourcing and training requirements, facilities, equipment or products.
Our services include:
Facility review or design
Process scale-up
Computer systems validation
Facility, equipment and utility validation
Process validation
Tech or design transfer
Troubleshooting
Our experts have comprehensive knowledge of regulatory requirements and agency interactions as well as the technical expertise to solve complex issues. We utilise a systems-based approach to compliance within the major pharmaceutical subsystems, including facilities and utilities, laboratories, material controls, production systems and packaging and labelling.
Expertise in Dosage Forms & Manufacturing
PQP covers the manufacture of all major dosage forms, including sterile and biotech products. We have experience in the following areas:
Pharmaceutical packaging
Sterilisation applications and processes
Pharmaceutical microbiology
Supply chain assurance
Good Distribution Practice (GDP)
Process and analytical method validation
Regulatory compliance for computers and automated control systems
Pharmaceutical water systems
Providing guidance on product manufacturing and product specifications, including the review and preparation of chemistry, manufacturing and control filings
Troubleshooting and investigation into product issues
Suggesting and implementing appropriate and robust corrective actions and preventive actions
Improving and simplifying product- or process-specific documentation
Our Services Include:
Providing guidance on product manufacturing and product specifications, including the review and preparation of chemistry, manufacturing and control filings
Troubleshooting and investigation into product issues
Suggesting and implementing appropriate and robust corrective actions and preventive actions
Improving and simplifying product- or process-specific documentation
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.
