About Us

Consulting in foods, cosmetics, disinfectants, medicine and medical device regulations and quality / laboratory management systems

Systems developed to comply with both national and international industry standards and frameworks including PIC cGMP, ISO13485, ISO 9001, ISO 14001, OHSAS 18001, ISO 22000, HACCP & ISO17025

Development of Policies, Procedures, Practices, Documentation requirements (where applicable e.g. MRF, Technical dossier), Risk Management Methodology, Internal Audits, Corrective and Preventive Actions and Continuous Improvement.

Good Manufacturing Practices (GMP) e.g. cleanroom design, hygiene controls, through the implementation and re-alignment to international business standards

Best practice in the areas of Medicine and Medical device regulation, Quality Management, Environmental Management, Health & Safety Management, Food safety management and Corporate Governance.

Medicine and Medical device regulation Environmental Management Food safety management and Corporate Governance surgical mask

 

 Experience includes:

  • Medical device, Foods, medicines, cosmetics and disinfectants production management with Technical services in product innovation and stability / validation programs
  • Quality Assurance and foods/ cosmetics/ disinfectants/ medicine / medical device regulatory affairs expertise
  • Good Laboratory Practices in the management of the microbiology, analytical and textile laboratories
  • Consulting on regulatory and clinical topics and medical aid re-imbursement for medical devices together with Health technology assessment both South Africa and Africa
  • Application of Occupational Health and Safety; including clean room and hazardous biological agent regulations and Good Healthcare Facility Practices
  • Consulting, project management and design on projects to build and implement GMP for a pharmaceutical, medical device, toiletries,cosmetics, disinfectats , food products and laboratories

Contact Simone on

082 871 5740
simone@isohealthsa.co.za


Removing RISK by linking business to ISO standards, legal compliance and GBP(Good Business Practice)

Contact Rudolph-Shortt Consultancy



Joint venture for project management GMP renovations and new facilities

Compliance Projects


R-SC Training

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