• Qualified Person services as per Directive 2001/83EC

  • Quality improvement programmes based on Kaizen and tailored to company requirement

  • Quality Systems implementation and compliance programmes

    • Pharmaceutical Quality Systems (ICHQ10 basis)

    • ISO2001:2016

  • Responsible Person services as per 2013C/ 343/01 and RP-I from January 2021

  • Provision of MIA & WDA licences in conjunction with trusted partner organisation

  • Deployment of GXP artwork origination standard as developed by CommQP

  • Auditing pharmaceutical artwork studios 

  • GXP training appropriate for pharmaceutical artwork studios

  • Outsourcing artwork capability 

  • Sourcing and evaluation artwork systems providers

  • Pharmaceutical packaging design and patient information leaflet user testing
    (in collaboration with a CommQP partner company)

  • Training in:

    • cGMP

    • GDP

    • Artwork origination GXP

    • Supply chain management

  • Bespoke in house training covering topics such as problem solving skills, CAPA & Quality Risk Management

  • Training can be remote or on-site

  • GMP & GDP audits cover:

    • Active Pharmaceutical Ingredients  

    • Finished dosage forms

    • Excipients

    • QC laboratories

    • Warehouses

    • Artwork studios

  • ISO9001

  • Inspection readiness & Remediation programme

  • Provision of GXP gap analysis audits in preparation for new MIA & WDA submissions or reassessments

  • Supplier sourcing and establishing supply chain  

  • Supply chain efficiency projects based on LEAN principles 

  • Market research & business development with Indian pharmaceutical and biotech companies

  • Defining procurement and supply chain management strategy for companies in Life Sciences sector

  • Preparation of CTD for Marketing Authorisation application

  • Ongoing contact with regulatory authorities on behalf of MA holder

  • Regulatory audits

©2021 by CommQP Ltd. 

Registered in England.

Company No. 8022888

VAT Registration No. 132072652