INDUSTRIES OF APPLICATION

  • Pharmaceutical

  • Health Products and Complementary medicines

  • Veterinary

  • Dental

  • Medical devices

  • Foodstuffs and cosmetics

OUR STRENGTHS

A wealth of credible and longstanding regulatory experience: over 30 years accumulated in-house.

Strong foundation in every sphere of the pharmaceutical industry, including Research, Clinical, Retail and Academic fields
 

We pride ourselves with extensive networking within the South African medicines and healthcare industries
and we are actively involved with professional and trade associations such as;

 

 - MCA (Marketing Code Authority)

 - SMASA (Self Medication Association of South Africa) (Regulatory and Technical Committee Member)  

 - SAPRAA ( Southern African Pharmaceutical Regulatory Affairs Association) 

 - GBMSA (Generic & Biosimilar Medicines SA)

 - PSSA (Pharmaceutical Society of South Africa)

 - SAAPI (SA Association of Pharmacists in Industry)

 - SAPC (South African Pharmacy Council)

 

We offer modular-type services that suit your needs and requirements, covering all aspects of product and business development from:

 - business development (licensing, market analysis and product feasibility)
 - to product registration
 - to marketing and distribution
 - and ongoing regulatory, administrative and marketing support

 

We are a highly responsive and dynamic team with an individualised, interactive and transparent working philosophy. Pro-active Regulatory and legal compliance advisory services regarding applicable legislation

INTEGRATED STRATEGIC SOLUTIONS:
MODULAR SERVICE OFFERINGS

SERVICES INCLUDE

TECHNICAL AND REGULATORY:-

-   Review of regulatory information with a deliverable gap analysis report of data

-   We have eCTD capabilities (Extedo - the same eCTD as the MRA), Utilisation of eCTD technology will save       

     you valuable registration time and money   

  

-   Registration dossier life cycle management

-   Reviewing formulation ingredients for claim and labeling compliance

 

-   Development of package inserts and patient information leaflets (SmPc)
 

-   Advertising compliance: avoid the embarrassment and consequences of having a published advertisement

     found to be in conflict with local requirements.  We screen promotional material giving confidence that

     marketing and advertising complies with local regulatory standards;
 

-   Regulatory liaison with the Regulatory Authority(ies)
 

GLOBAL AUDITING SERVICES:-

-  GMP and Quality Assurance consultations
 

-  Our Global Auditing services offer GMP assessments of manufacturing, packaging and distribution facilities
 

DEVELOPMENT OF:-
 

-  Site Master Files

-  Standard Operating Procedures

-  Quality Management Policies and Manuals 
 

Technical agreements with 3rd party contractors: we will facilitate in the setting up of and establishing the required technical agreements with:

 

  • Manufacturers and Packers

  • Laboratories

  • Warehouses

  • Distributors

  • Printers

  • Advertising Agencies

  • Marketing Agencies

  • Pharmacovigilance

BRAND DEVELOPMENT:-

At MC Pharma we have an in-house marketing department which will ensure a cohesive brand strategy for you to increase market share contributing to company growth and profitability.

OTHER SERVICES INCLUDE

- In- and out-Licensing of products are an essential component of a company's growth and subsistence

- Licensing strategy

 

- In-licensing of products for local commercialisation utilizing Marketing Authorisations under MC Pharma’s name;

  Facilitation of product acquisition, including the evaluation of registration dossiers and supporting regulatory 

  and registration documentation;

    

- Product feasibility and positioning
 

- Market assessment and analysis
 

- Commercialisation of product including marketing
 

 

TRAINING:-

Your employees are your company's greatest asset - make them your competitive advantage.

We provide brand and sales training and development for Sales Representatives as well as individual hands-on personalised training programs to meet your specific needs, including all aspects of:-

  • Registration and regulatory technical and regulatory

  • Package insert and patient information leaflet development 

  • Advertising compliance and

  • GMP, including Site Master File development, SOP and Quality Management Policies 

TRANSITIONAL ARRANGEMENTS
FOR MEDICAL DEVICES

Kindly be advised that the Medicines Control Council resolved on the transitional arrangements for medical devices, to allow for the sale and use of medical devices, under the ambit of the Medicines and Related Substances Act, 1965 (Act 101 of 1965) as amended.

© 2020 COPYRIGHT MC PHARMA