top of page

SERVICES

Qualified Person & Responsible Person

  • 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

Artwork Origination

  • 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

  • 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

Auditing

  • 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

Procurement

  • 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

Regulatory Affairs

  • Preparation of CTD for Marketing Authorisation application
     

  • Ongoing contact with regulatory authorities on behalf of MA holder
     

  • Regulatory audits

bottom of page