Services

Front-End Design & 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 project implementation. 

 

 

 

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 others.

 

After Sales Support

Pharmadule continues to serve you even after your project is installed and in operation. We can be your partner when it comes to keeping your facility and equipment in good working order and your production running smoothly.

Should you require technical assistance, Pharmadule's After Sales Support Department can help you with:

  •  Spare parts
  •  On-site service
  •  Service contracts
  •  Documentation
  •  Training
  •  Upgrades, renovations, etc.
  •  Warranty issues

 

Pharmadule Morimatsu AB  |   DanvikCenter 28  |   SE - 131 30 Nacka  Sweden  |   Phone: +46 (0)8 587 42 000  |   Email: info@pharmadule.com