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:

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.

 Accreditation