Sachuma Pharma Consulting

Johannesburg

0118059795/0824291128

Our Services

Our consulting services are geared to meet pharmaceutical and medical devices regulatory requirements. We pride ourselves by the ability to work together with clients to exceed their expectations.

Our consultants are lead auditors of ISO 9001: 2015 Quality Management System and ISO 13485: 2016 Medical Devices standards.

01

Licence Applications

We are the Hub of pharmaceutical and medical devices establishments licensing in South Africa, we specialise in the following.

  • Pharmaceutical manufacturers, distributors, and wholesalers
  • Medical devices manufacturers, distributors, and wholesalers
  • Category (D) medicines manufacturers, distributors, and wholesalers
  • Cannabis cultivation manufacturers, distributors, and wholesalers

02

Quality Management System

We assist clients navigate the complexities of establishing QMS in pharmaceutical and medical devices industries.

We implement ISO 9001:2015 Quality Management System and ISO 13485: 2016 Medical Devices.

In addition, our team of quality pharmacists assist clients to write and review

  • Standard Operating Procedures (SOP)
  • Quality Manual (QM)
  • Site Master File (SMF)

03

Training

The pharmaceutical and medical devices industries are highly regulated and staff training and competency goes hand in hand.

We develop a training needs analysis tailor-made for your business and deliver practical training to meet the industry needs.

  • Regulatory training for new Responsible Pharmacists
  • QMS training
  • Curriculum development for pharmacy support personnel

04

Temperature Mapping and Validation

Cold chain products and vaccines are highly sensitive to temperature variations. These products need to be manufactured, stored, and transported at controlled temperatures to retain safety, quality, and efficacy (2 °C to 8 °C).

We assist pharma manufacturers, distributors, and couriers to conduct temperature mapping.

  • Cold rooms and storage areas
  • Packaging material validation
  • Transport validation

05

Project Management

Sachuma Pharma taps from diverse skills and expertise of their team and has successfully completed intricate client projects.

  • Pharmaceutical plant design and warehouse space optimization
  • Recruitment and placement of pharmacists
  • Teaching and research
  • Due diligence on acquisitions
  • Marketing and business plans

Comprehensive pharmaceutical and medical devices licensing services

Quality compliance can help you get there.