Pharmalane UK
Provider of third-party pharmaceutical quality and regulatory services with over 15 years' experience. Services include GxP auditing (GMP/GCP/GPvP/GDP/GLP), supplier qualification, a maintained library of ready-to-procure audit reports, regulatory affairs and dossier support, pharmacovigilance advisory, and inspection-readiness services. Operates globally with offices in the UK and Asia.
Industries
Nr. of Employees
medium (51-250)
Pharmalane UK
London, England, United Kingdom, Europe
Products
Audit Reports Library (ready audit reports)
Catalog of ready audit reports prepared by qualified auditors covering multiple manufacturers and sites; reports can be procured to support supplier qualification without commissioning a new audit.
Audit Reports Library (ready audit reports)
Catalog of ready audit reports prepared by qualified auditors covering multiple manufacturers and sites; reports can be procured to support supplier qualification without commissioning a new audit.
Services
On-site and remote third-party audits for GMP, GDP, GLP and related standards including planning, auditing, reporting and audit closure.
Full clinical trial audits, CRO audits, investigator site audits, system and document audits, and mock inspections for clinical trial compliance.
Audits of PV systems and processes, vendor PV audits, signal detection and aggregate reporting assessments.
Regulatory strategy, gap analysis, dossier compilation (including CMC/IMPD/IB), eSubmissions, translations and lifecycle management.
Access to a maintained library of ready-to-procure audit reports prepared by qualified lead auditors to fast-track supplier qualification.
Preparation for regulatory inspections including mock inspections, staff training, document readiness checks and on-site coordination during inspections.
On-site and remote third-party audits for GMP, GDP, GLP and related standards including planning, auditing, reporting and audit closure.
Full clinical trial audits, CRO audits, investigator site audits, system and document audits, and mock inspections for clinical trial compliance.
Audits of PV systems and processes, vendor PV audits, signal detection and aggregate reporting assessments.
Regulatory strategy, gap analysis, dossier compilation (including CMC/IMPD/IB), eSubmissions, translations and lifecycle management.
Access to a maintained library of ready-to-procure audit reports prepared by qualified lead auditors to fast-track supplier qualification.
Preparation for regulatory inspections including mock inspections, staff training, document readiness checks and on-site coordination during inspections.
Expertise Areas
- GxP auditing and supplier qualification
- Clinical trial (GCP) auditing and inspection readiness
- Pharmacovigilance system audits
- Regulatory affairs and dossier compilation
Key Technologies
- Electronic data capture (EDC) and TMF systems
- Regulatory eSubmissions
- Global safety databases and PV systems
- Audit management systems and searchable report libraries
News & Updates
Article about GMP compliance and services for pharmaceutical manufacturers.
Article covering benefits of partnering with an external GMP auditing provider.
Discussion of the need for formal auditor qualification, routine training, and performance evaluation to maintain audit quality and regulatory compliance.
Overview of internal and external quality audits in the pharmaceutical industry and recommended procedures for conducting detailed audits.
Award winner noted on company site.
Award finalist listed on company site.
Article about GMP compliance and services for pharmaceutical manufacturers.
Article covering benefits of partnering with an external GMP auditing provider.
Discussion of the need for formal auditor qualification, routine training, and performance evaluation to maintain audit quality and regulatory compliance.
Overview of internal and external quality audits in the pharmaceutical industry and recommended procedures for conducting detailed audits.
Award winner noted on company site.
Award finalist listed on company site.