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Because the Pharmaceutical Industry is (justly) quite rigorous and requires many steps to be taken, certificates to be filled out and many document (IQ, OQ, and PQ to name a few) to be provided before a certain product can be placed onto the market. It may get quite overwhelming and sometimes even confusing.

We are here to help you find your way through this maze of procedures and offer you support in the verification and validation process:

  • User Specification Document

  • Molding Tools Specification Documents

  • Equipment Validation and Qualification Documents

  • Handling Study

 

In the case of DPIs, the drug must be mixed with an excipient, before being loaded into the inhaler. When the drug is inhaled by the patient it is actually a drug/excipient mixture that will separate during its way the patient’s airways, before reaching the lungs. It is sometimes challenging to create a drug/excipient mixture that has a uniform blend to ensure an accurate dose and repeatability of drug delivery.

 

Other challenges may come from looking for the right supplier or coping with machine set-up.

 

We can help you with such challenges offering assistance in: 

  • Powder formulation

  • Filling machine set-up

  • Supplier evaluations

  • In-vitro testing

  • And more...

 

 

For more information, please contact us! 

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