Quality
GMP
GMP
A successful supply chain is only as good as its quality systems. Quality is
not simply a support service but rather an integral component of the supply
chain. This is true whether the manufacturing is to fuel your clinical trials or
your sales force. Robust quality systems must be fine-tuned to maintain the
assurance of the quality of the products for the customers (patients) but also
be attentive to the needs of the other customers (Sales and Clinical
Development).
As products move through the pipeline, our knowledge increases along with
our experience. Our quality requirements must adjust in harmony to the
changing environment.
Calcott Consulting staff has many years experience developing,
implementing and fine tuning quality systems to meet all these critical steps
in the product life cycle. We have developed systems from scratch and
modified pre-existing systems to meet business needs.
not simply a support service but rather an integral component of the supply
chain. This is true whether the manufacturing is to fuel your clinical trials or
your sales force. Robust quality systems must be fine-tuned to maintain the
assurance of the quality of the products for the customers (patients) but also
be attentive to the needs of the other customers (Sales and Clinical
Development).
As products move through the pipeline, our knowledge increases along with
our experience. Our quality requirements must adjust in harmony to the
changing environment.
Calcott Consulting staff has many years experience developing,
implementing and fine tuning quality systems to meet all these critical steps
in the product life cycle. We have developed systems from scratch and
modified pre-existing systems to meet business needs.
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Our services are very broad and include the following:
 | Development of a Quality Vision and Mission | |
| Development and implementation of Quality strategy and Quality | |
| manuals to meet the spirit of ISO, ICH Q8, 9 & 10 and Quality by Design | ||
| Development of quality systems de novo or optimisation of pre- | |
| existing systems | ||
| Our speciality is change control, deviations and investigations, | |
| CAPA, training, lot disposition, RM systems, documentation, complaints, method validation and specification setting | ||
| Development and implementation of independent audit systems | |
| Translation of business processes into robust e-systems, using | |
| this opportunity to optimise and fine tune your business process | ||
| Managing change in the organisation as processes change in | |
| response to business needs | ||
| Integrating Quality into the Supply Chain | |
| Development and implementation of working relationships with | |
| vendors including Quality Agreements and Persons in the Plant | ||
| Development of training, certification and learning management | |
| systems. |
We look forward to working with you to meet your business challenges.