Manufacturing Support:
Developing manufacturing plans and supply projections
Proposing, qualifying & managing vendors, such as contract GLP/GMP labs, and contract GMP manuacturers for API or drug product
Provide Quality related training
Reviewing or preparing standard operating procedures (SOPs)
Providing input into the development of test methods and product specifications
Designing stability testing programs and selecting test parameters
Structuring corporate quality systems
Assessing compliance with current Good Clinical Practices (cGCP) Good Manufacturing Practices (cGMP), and Good Laboratory Practices (cGLP)
Providing on-site instruction in cGCP, cGMP, and cGLP compliant systems
and practices
and practices
Providing input and reviewing validation protocols and reports
Auditing suppliers and CMOs, including “mock” regulatory inspections
Review of batch documentation and release/disposition of drug products & quality management of Contract Facilities
Secondary Packaging/Logistics Support:
Clinical packaging, storage and distribution (Phase I – III)
Designing and producing labels (multilingual capabilities)
Kit assembly
Producing and shipping individually packaged product for dose titration studies
Rework services, such as over-labeling, re-labeling, and expiry update labeling
Warehousing and shipping of ancillary clinical materials
Sourcing comparator drugs
Global transport and chain of custody planning
Managing returns, including accountability and certified destruction
Warehousing and distribution of commercial stage promotional materials
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Malvern Consulting Group 490 Lapp Road,
Malvern, PA 19355
