Lowden International
Lowden International is an alliance of expert consultants, formerly from Industry and Regulatory Authorities. We specialise in helping pharmaceutical and biotechnology companies to pass GMP/GCP regulatory inspections.
Our approach is based on implementing effective Quality Management to achieve permanent Inspection Readiness. Our unique “7-Pillars” model is a valuable tool for developing a robust Pharmaceutical Quality System across the whole product lifecycle.
We offer auditing and training in GMP, GCP, Inspection Readiness and Quality Management.
We invented Live Line Clearance (PAT for packaging) which has been implemented worldwide.
Contact details
Company details
- Design and improvement of pharmaceutical Quality Systems (ICHQ10)
- Implementation of pharmaceutical Quality Systems across the whole organisation - between sites and across the whole product lifecycle
- Implementation of Live Line Clearance into packaging operations
- Customised in-house training in all aspects of GMP, GCP, GQCLP and Quality Management
- Mock inspections, audits and inspection readiness projects
- Good Clinical Practice Services
- GMP for Investigational Medicinal Products
- GMP/GCP interface in Hospitals and CROs
- Auditing of Contract Manufacturers, Laboratories and Suppliers
- Updates on pharmaceutical legislation
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