WHO / PIC/S / MCC GMP and Validation Consultants

What we offer:

GMP Training - PIC/S and WHO

• We offer a wide range of GMP training and GLP training courses and certification.

People

• Outsourced consultants to work on your site under your direction at short notice for short or long duration projects. Our staff are experienced MCC consultants, FDA consultants and MHRA consultants.
• We have Pharmaceutical Engineers, GMP Consultants, Validation Consultants, and Technical Document Writers available at short notice at competitive rates.
• We supply Engineers to review your plant design as well as other general engineering services.

GLP/GMP Compliance

• GLP/GMP Quality Management Systems or Quality Management Systems or GAP audits and assessments
• Practical recommendations and advice on the implementation of ISO 9001 for Pharmaceutical or ISO 13485 for Medical Device Quality Management Systems, Policies, SOP and Forms.

Validation - Process, Equipment & Computer

• Pharmaceutical Process Validation to MCC, PIC/S, WHO and FDA regulations,
  
• Pharmaceutical Equipment Validation to international regulatory standards and in accordance with current Good Manufacturing Practice.
• Cleaning validation for pharmaceutical and medical device manufacturing facilities

Regulatory Affairs - Drug registrations

• Providing advice and answering your questions on the South African Medicines Control Council (MCC) drug registration process
• Preparing dossiers to support a drug registration with the MCC.

More about our services

Who we are:

With offices in Pietermaritzburg, we operate throughout South Africa, Australia and the Asia Pacific. PharmOut consultants pride themselves on the practical application of regulations. Each have many years of industry experience. Experience that has seen most of the problems that can occur in manufacturing and development. Experience that can prevent you making mistakes - or solve them if it is too late.

As pharmaceutical consulting professionals it is our job to stay up to date with current regulations so that we can be sure our customers comply. Have you got time to read them all, let alone ensure that you comply? 

Who will benefit from our services?

Quality Assurance professionals, Manufacturing and Engineering Managers within pharmaceutical companies looking to enhance business profits and export to international markets.

 

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