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.

 

 

With proper quality systems in place, your company can 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 Statistical process control systems, wireless temperature, humidity, pressure differential, Carbon Dioxide, LUX and Ethylene monitoring systems and Control Access solutions that can be used for Clean Room Airlocks.

 

 

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