PHARMACO

To get your product to market in the pharmaceutical or medical device industries you need to implement GXP systems that comply with stringent European and US legislation. Pharmaco offers a consultancy service to industry for quality and regulatory system compliance.

 

 

If your business is nutraceutical in nature, we can help you interpret the required feeding stuffs regulations and develop quality systems based on the required regulation.

 

 

Get your product to market faster by knowing what type of key indicators the regulators will be looking for during their inspections.

 

With proper systems in place, it will allow your company to get authorisation for your Manufacturing Facility, Drug or Medical Device faster.

 

Not having proper quality procedures in place can be very costly to your business. Loss on time to market due to missing new regulation requirements or closed facilities due to citations.

 

 

Pharmaco Consulting can also assist you with Cleanroom design, Compliant air systems (HVAC), water systems for pharmaceutical grade water or WFI, site master file preparation, Drug master file preparation, pre-inspection audits, regulatory issues, development and validation of methods, testing criteria for pharmaceutical product release and interpretation of the relevant guidelines: e.g. GMP, VICH, ICH and relevant Pharmacopoeia.

 

 

If you are a business Entrepreneur

and are thinking of starting up your own Pharmaceutical, Nutraceutical or Medical Device industry, PHARMACO have the experience to help you get your company started.

 

 

Pharmaco Consulting also supply calibration and validation software management applicatons, LIMS systems, Statistical process control systems, wireless temperature, humidity, pressure differential, Carbon Dioxide, LUX and Ethylene monitoring systems.

 

 

Pharmaco implement and support all 21 CFR Part 11 compliant software and validated hardware systems.