Front-End Design and Pre-Engineering
With your process in mind, we guide you through a fast track
Front End Engineering phase to develop an optimized design for your
pharmaceutical or biotech facility project.
Pharmadule's Front End Design team consists of multi skilled
professionals with direct experience from pharmaceutical
manufacturing, design and process technology. We focus on moving
quickly and effectively through the front end design phase ensuring
that your requirements, time schedule, and budget are met.
We help you identify risks early securing a predictable project
execution and address flexibility to guarantee that your best
operating criterias will be met. Properly executed this phase
provides the key to a cost-effective and successful facility
Quality Assurance and Validation Management
Our Quality Assurance and Validation team has extensive
practical know-how on current regulatory requirements
(FDA/EMA/SFDA/GMP), and several local regulations. The work-model
takes into account the latest developments in the field,
incorporating Quality Risk Management principles into all parts of
the work flow.
In combination with the modular facility delivery, Commissioning
and parts of the IQ/OQ are performed at the vendor workshop, and in
Pharmadule's own assembly facilities. The final steps of
Qualification and the Process Validation are performed at the final
site, often together with the client's QA and Validation team. This
allows for a fast delivery without compromising quality.
Pharmadule can also act as a consultant, managing turn-key QA
and/or validation projects for all types of pharmaceutical and
biotech facilities. The team can also perform separate tasks: GMP
audits, Risk Management (deriving CQA/CPPs), writing Validation
Master Plans and designing GMP-compliant Quality Systems, and