GMP /GDP/ GxP Consultancy
GxP Regulatory Authorities Inspection Readiness
Pharmaceutical Quality System Compliance
EU and UK Batch import/testing and release and Distribution
QP/RP/RPi services
GxP Regulatory Authorities Inspection Readiness
- QW partner, we maintain alignment with new, existing, and changing regulations and industry standards that evolve throughout the drug product and device lifecycle.
- QW auditors have real-world experience supporting regulatory inspections and preparing companies for pre-approval inspections. QW UK/European-based third-party EU GxP auditor will thoroughly assess the facility’s readiness before inviting the UK/EU regulators for the audit.
- QW’s team of specialists includes former/current EU/UK qualified personnel and IRCA and IRCA certified and qualified auditors who are proficient in conducting mock inspections, internal audits, vendor and supplier auditing, and gap assessments.
- QW team and consultant worked and working with partners for manufacturing of Non-sterile, sterile and ATMP manufacturing facilities
- QW consultants since 2015 worked with 5+ manufacturing facilities in the UK and Asia to set up QMS and facility to manufacturer and supply pharmaceutical medicines in the UK, South Korea, India and EU
- Facilities we offered services and working with:
Non-sterile dosage
form manufacturing, including Solid Orals (including extrusion process),
Liquids and Topical Preparation
Sterile and aseptic
Small molecules, Manufacturing, Nasal Spray, Ophthalmic dosage forms, Liquid
and Lyophilised products
Aseptic manufacturing
of large molecules, including mAbs, ATMP (Cell and Gene Therapy), Vaccine
biologics and Biosimilars
Pharmaceutical Quality System Compliance
- QW consultant helps clients overcome complex challenges with compliance consulting by identifying and mitigating risks, implementing improvement plans, and collaborating with clients to ensure quality and compliance.
- QW supports clients throughout the product lifecycle, from R&D to commercialisation, with quality and compliance consulting. QW delivers high-quality services with a diverse team of subject matter experts (SMEs) who have experience in various GxP areas and regulatory authorities.
- QW consultants have extensive management and operational experience in one or more GxP areas (GMP, GDP, GVP, GCP, GLP, GCLP, and/or IT/CSV). QW is flexible and passionate about delivering excellence in consulting services.
- QW consultant working with clients on critical or 483 observations issued by regulatory authorities for drafting and submitting responses and defining appropriate CAPAs.
- We serve as an extension of QW client’s Quality Department with respect to vendor and supplier/vendor or services provider selection, qualification and management.
EU and UK Batch import/testing and release and Distribution
- Since 2015, QW Consultant help 10+ customers to set up QMS as per UK and EU requirements and host MHRA/EMA inspections to get MIA/WDA
- QW collaborates with MIA-H and WDA-H experts and authorised testing sites in UK/EU
- QW can arrange EU/UK MIAs and include QW drugs on QW’s planned MIA license. This can enable MAH to enter EU/UK markets quicker and easier.
- QW QP consultant provides complete QP Batch Certification services for pharma and biotech clients in UK/EU since 2015
- QW has skills in various products/formulations such as biologics, ATMPs, vaccines and small molecules. QW can assist with new product launches and existing/routine batch releases.
- QW RP/RPi consultant can provide a wide range of GDP services and work with professional partners to provide distribution services in the UK.
QP/RP/RPi services
- QW Consultant QP is working with a wide range of commercial and clinical trial products, including.
- Non-sterile dosage forms (Solid oral, Liquid)
- Sterile (small molecules)
- Sterile (Biologics, Biosimilar, ATMP)
- QW consultant RP/RPi provide services to UK customers for UK distribution and EU/EEA importation and release in the UK.