GDR PHARMA Services
Our Services
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.
Provide Quality Control (QC) and Quality Assurance (QA) functions and responsibilities
Freyr eCTD Systems
Elevate your Regulatory efficiency with Freyr Regulatory Software. Streamline processes, ensure compliance, and conquer global markets seamlessly with our advanced Regulatory solutions.
Freyr SUBMIT PRO is an eCTD software that streamlines your Regulatory submissions. With its submissions capabilities it is one of the best eCTD software’s in the market. As a trusted eCTD vendor, we offer excellent support and updates to ensure you are optimized for compliance.