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