Medicines Control Council ( MCC ) GMP compliance and pharmaceutical validation consultants

PharmOut South Africa is a MCC GMP consultancy and is part of the network of PharmOut companies. In South Africa, we offer Medicines Control Council MCC GMP consulting, pharmaceutical validation and GMP training to help pharmaceutical, medical device and complementary medicine manufacturers achieve MCC GMP, MHRA GMP, EU GMP, PIC/S GMP and/or WHO GMP compliance. Details of our products and services are listed on our global website.

We focus on the practical application of regulations to achieve compliance in the GMP manufacturing world. Our MCC GMP consultants are familiar with most of the GMP problems that occur in regulated facilities like Pharmaceutical, Medical Device and Biotechnology manufacturers.

We work with multinationals and small start up companies. Typically, we help Quality Assurance, Validation Managers and Engineering Managers within pharmaceutical companies who want to increase profits and export to international markets by having their staff understand and work towards becoming GMP compliant.

Our Team

Our team includes:

• MCC GMP Consultants
• Pharmaceutical Validation Consultants
• TGA Regulatory Affairs Consultants - to support product exports to Australia
• Professional GMP Trainers
• Technical Writers and other life science specialists.

We can provide experienced consultants or contractors at short notice.

PharmOut’s team includes international GMP experts and consultants who previously held leadership roles within regulatory bodies such as PIC/S.

More information about our GMP compliance services can be found on our global website.

Our industries

PharmOut consults to those industries subject to the various GMP codes regulated by Medicines Control Council, PIC/S, MHRA, GHTF, FDA and the EU, including:

• Pharmaceutical manufacturers
• Medical device manufacturers
• Manufacturers of veterinary and pesticide products.

Using a risk based approach, we target the areas that will have the most impact on product quality – rather than simplistically treating the whole process equally.

More information about the industries we support is available on our global website.

The projects we take on

• GLP/GMP Quality Management Systems, compliant with MCC GMP codes
• Audit readiness assessments and audit remediation to FDA CFR 210/211, CFR 820
• Implementing Quality Management Systems for Pharmaceutical or ISO 13485 for Medical Device standards
• Assistance with obtaining approval from international Regulatory GMP bodies such as the FDA, EMA, MHRA Part 11 and Annex 11 compliance to FDA requirements
• Preparation of dossiers for drug and device registration with the Australian TGA.

Read case studies of our work on our global website.

Contact us

Contact details for our South African office and international offices.