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Medicijn Ontwikkeling

The drug development process from discovery to commercialisation is not only lengthy and costly, but also involves compliance with an ever-increasing number of Regulatory requirements and expectations. Unless product development and licensing strategy are closely harmonized to ensure that key Regulatory milestones are achieved in time, avoidable and potentially costly delays may be incurred.

HPCS are able to provide expert strategic and practical guidance to development organisations in negotiating the various Regulatory hurdles from early Phase I Clinical studies through to market launch. Support can be provided in the following areas:

• Definition of optimal product development timelines and Regulatory submission milestones to ensure ?Fastest Time To Market?
• Implementation and monitoring of GMP principles in Clinical Trial Manufacturing Units and Pilot Plants (Annex 134), both for API and FDF
• Qualified Person support for Clinical Trial supplies release (Annex 16)
• Development of process validation strategies
• Preparation and submission of IMPD documentation for Clinical Trial Ethics Committee reviews and approval
• Development of comparability protocols for product transfer and scale-up (EU and US FDA), as well as post-approval changes
• Preparation of Development reports
• Preparation and coaching for EU and US Pre-Approval Inspections
• Implementation and Monitoring of GLP principles in those laboratories required to meet OECD GLP regulations
• Evaluation of contract manufacturers, analytical services and development organisations
• Third Party for compliance to GMP and GLP
• Due diligence audits as a prelude to project / product acquisition or process transfer
• Documentation review and critical assessment for Regulatory compliance and acceptability

With its expert team of pharmacists, chemists, microbiologists, engineers and Regulatory Affairs specialists, HPCS can provide technical support and advice to most drug development programmes, in order to ensure cost-effective and timely compliance to both EU and US FDA regulations.