Pharmaceutical Quality & Operational Services

Offering a wide range of QP, QA, GMP and regulatory services, we contract with logistics and warehousing companies to facilitate importation of drug product into the European Union.

We operate a validated electronic Quality Management System for importing and QP release of Marketed and Clinical Trial Medicinal products and hold Manufacturing and Importation Licenses from the Irish Regulatory Authority (Health Products Regulatory Authority).

Qualified Persons & Quality Services

  • Provision of wide range of QP, QA, GMP and regulatory services. 

  • Our associates are Qualified Persons (under directives 2001/83/EC and 2001/20/EC) and can provide general support and/or batch certification for a range of products for investigational (clinical trials) or commercial use.

  • We also offer auditing services, on site or remote quality/technical support and Quality System development.

Investigational Medicinal Product (Clinical Trial Supplies) Expertise

Investigational Medicinal Product (Clinical Trial Supplies) support from Phase I to IV including, importation and certification of investigational products.

Facility Preparation, Auditing & Supplier Management

  • Facility auditing and supplier management of API manufacturers.

  • Contract manufacturing, packaging or testing facilities, and general contract manufacturing sourcing.

  • Facility preparation & readiness for gaining new manufacturing authorisations, product license approvals, regulatory inspections, product license variations, self-inspections, customer audits and corporate audits.

Quality Systems & Operations 

  • Development and Implementation of Quality Management System

  • Design and Documentation of Quality Systems

  • Validation and Qualification

  • Quality Assurance (Batch Record Review, SOP development, etc.)

  • Quality Remediation

  • Management and Design Controls

  • Risk Management

  • Manufacturing Compliance Oversight

  • Manufacturing Engineering and Support Project Management

Licensed for Importation & QP Release of Medicinal Products

We hold Manufacturing and Importation Licenses from the Irish Regulatory Authority (Health Products Regulatory Authority), contract with logistics and warehousing company to facilitate importation of drug product into the European Union, and ensure requisite GMP and regulatory needs are met.