MedReg Consultants are strategic outsourcing partners to the pharmaceutical and allied health care industries in Southern Africa offering professional support to the pharmaceutical and related industries.

The industries that are served are:

• Pharmaceutical

• Veterinary

• Dental

• Complementary medicines

• Medical devices

• Foodstuffs and cosmetics

Services That We Provide:

• Compilation and updating of registration dossiers – orthodox and complementary medicines;
   

• Registration of farm feeds and agricultural remedies under Act 36 (Department of Agriculture);
   

• Compilation of package inserts and patient information leaflets (PIL);
   

• Advertising compliance;
   

• Screening of data to ensure compliance with registration requirements and registration feasibility;
   

• Assessing registerability of products;
   

• Reviewing cosmetics and foodstuffs for ingredients, claim and labeling compliance;
   

• GMP and Quality Assurance consultations and GMP assessments of manufacturing, packaging and re-packaging facilities;
   

• GMP training consisting of class room and hands-on training of factory workers at all levels, including “train-the-trainer”;
   

• Assessment of distribution warehouse, including the structure, systems and documentation in terms of Good Warehouse Practice / Good Wholesale Practice / Good Manufacturing Practice and Good Distribution Practice;
   

• Compilation of Standard Operating Procedures and Site Master Files;
   

• Skills development with regards to dossier evaluation;
   

• Assistance with technical agreements with 3rd party contractors;
   

• Liaison with the Regulatory Authority(ies);
   

• Independent QA/RA and operations compliance auditing;
   

• Licensing requirements;
   

• Regulatory compliance consultation

MedReg Consultants have successfully been involved in training and assisting the Drug Regulatory Authority (DRU) in Botswana in evaluating approximately 1 000 product dossiers and offering classroom and in-house training to the DRU inspectors in GMP inspections and report writing and data verification.

MedReg Consultants currently consult to more than 100 clients from various industries. The focus being on planning and on minimizing delays due to regulatory non-compliance with a commitment to provide the range of support that meet each client’s needs.

Client confidentiality is unequivocally maintained and internal quality systems assure complete client confidence. Through commitment to clients, long-term relationships are established and maintained.
Projects are accepted on a quotation basis.

Consider the following:

• Up to date regulatory knowledge
• Expertise and experience “on tap”
• Technology
• Availability
• Flexibility
• Reducing your regulatory workload
• Ensure a positive inspection report

Contact Us For More Information

Contact MedReg Consultants

Tel no: +27 (0)12 686 7123
Fax no: 086 606 5405