SAHPRA ACCREDITED - IMPORT/EXPORT LICENSE FOR MEDICINES AND MEDICAL DEVICES

Our Services

Our Focus

Africa Expansion

Prioritise country expansion based on ease of doing business, regulatory complexities, return of investment and in-market opportunities
Partner with local distributors in-country based on their distribution footprint, warehousing, regulatory, sales and marketing capabilities

Regulatory

Act as an Applicant / Marketing Authorisation Holder in South Africa and Rest of Africa on behalf of prospective Principal company.
Regulatory Assessments and Regulatory Intelligence
Product due diligence, evaluations (Medicine, Complementary products, Medical Device) and submission for registration – ensuring 1st time, right time approvals
Import clearance, post importation testing & release into market ​
Pharmacovigilance & Compliance (variations, renewals, SOP’s, Inspection support, trainings)

Supply/Distribution

Forecasting 
Tender submission
Managing the supply chain with distributor in-market
Management of all accounts and collections
Warehouse management & Quality Control in market

Sales, Marketing & Promotions

Fostering sales, marketing and promo strategies, partnering with the Principal company and Distributor in-country
Development of market access strategy to expand
Lobbying & Engagement with Health Ministries

Total Quality Management

Pharmaceutical Quality System Development
Product Technical Transfer Management
Process & Quality Management Support
Quality Risk Management
Process Validation
Utility (Water, HVAC, Compressed Air), Equipment and Laboratory Qualification Services
Supplier’s Assessment and Qualification Page Break