We offer a range of pharmaceutical quality assurance services which can be tailored to a specific need or requirement.

We primarily have 3 potential models of operation:

  • Site of Importation / QP Certification Only

  • Importation, Storage, Sampling, Analysis & QP Certification

  • Models 1 or 2, with the addition of Regulatory Management Services

We also offer a number of Quality Assurance support services, including:

QP & GMP - Pharmaceutical Quality Experts

  • Qualified Person Batch Release (Commercial & IMP)

  • MIA Importation & QP Certification / Declarations

  • Responsible Person & GDP Compliance Support

  • New Site Licencing (MIA, MIA(IMP), WDA) / Licence Changes

  • Supplier Quality Assurance Expertise

  • GMP, GDP, GLP & GCP Auditing Services

  • Manufacturing GMP Compliance - Gap assessment

  • CDMO Oversight & Management

  • QMS Improvement & Remediation Activities

  • Computer Systems Validation Services

  • Regulatory Affairs Services

  • Medical Device Expertise

  • Pharma / Device Combination Products

  • Software as a Medical Device

  • Medical Device Audits (ISO-13485, ISO-15378, SaMD)

We can provide any combination of tailored solutions to meet your requirements. Contact our team of experts today to see how we can help.

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