Areas of expertise

Quality Assurance

The history of the pharmaceutical industry has shown that Quality Assurance (QA) is crucial. The continuously increasing guidelines and regulations ensure that medicinal products meet the highest quality standards in order to ensure their efficacy and safety when using the products.

Our services

A selection of the QA services in2pharma offers

in2pharma has a wide experience when it comes to Quality Assurance. Our QA consultants are specialized in the good distribution practices (GDP), Good Manufacturing Practices (GMP) (importation and batch release) and have an extensive knowledge of the applicable Belgian, Dutch, and European legislation.

Non-exhaustive list.

Quality Management System

  • We establish and maintain a Quality Management System (QMS) to comply with GMP or GDP
    • Establish and continuously improve Standard Operating Procedures (SOPs) for all GDP/GMP processes
    • Management of the Documentation System
    • Training Management
    • Performing self-inspections / internal audits or external audits
    • Handling of quality complaints
    • Follow-up of Non-Conformances / deviations and Corrective & Preventive Actions (CAPA)
    • Establish Quality and Technical Agreements for all outsourced activities
  • We deliver Qualified Persons (QP) and Responsible Persons (RP) who can act as QP/RP for your company

Health authorities

  • We can support you during inspections in scope of new WDA or MIA license applications
  • We act as first point of contact for all questions from the Benelux health authorities

Selection of successful projects

  • Establishment of a complete new QMS for companies applying for a first MIA-license
  • Joint venture integration of two pharmaceutical companies into one common QMS
  • Host multiple health authority inspections for both WDA and MIA license applications
  • Upgrade of an ISO:13485 warehouse (medical devices) to WDA-license
  • Upgrade of WDA license to MIA license
  • Act as RP and maintain compliance in quality assurance (quality complaints, deviations, CAPAs, change control, training, SOP management, etc.)
Interested?

Interested? Get in touch!

From a first MIA licence to day-to-day RP duties — we can take it on.

Get in touch