GDR PHARMA Services
Our Services
Our Services
- Africa Expansion
- Regulatory
- Supply/Distribution
- Sales, Marketing & Promotions
- Total Quality Management
- Freyr eCTD Systems
- Regulatory affairs and MAH's services for veterinary products
- Pharmacy (Retail, Manufacturing, Applicancy, Warehouse and Distribution) Licence Applications & Compliance
- Medical Device Applications & Licensing
- Legal Representative Services with SAHPRA
- API Distribution
- Sieve Distribution
- Complementary Medicines, Nutraceuticals, Health Products etc,
- Interim Responsible Pharmacist and Deputy Responsible Pharmacist 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.
Regulatory Affairs and MAH's Services for Veterinary Products
GDR PHARMA is authorized to be MAH/ APPLICANT for any manufacturing companies that wants to expand in South Africa and neighbouring countries to distribute, sell, and commercialize veterinary medicinal products.
Service offerings:
- Marketing: GDR PHARMA is responsible for the marketing of the product.
- Safety and Efficacy: GDR PHARMA ensure the product meets safety, quality, and efficacy standards.
- Pharmacovigilance GDR PHARMA has a responsibility to monitor the safety of the product after it has been placed on the market and to report any adverse events.
- Variations: GDR PHARMA must report any variations in the conditions of their marketing authorization.
- Product Information GDR PHARMA are responsible for ensuring the product information (e.g., Summary of Product Characteristics, package leaflet) is accurate and up to date.
- Quality Assurance: Release of the product to the market and post marketing surveillance.
Pharmacy (Retail, Manufacturing, Applicancy, Warehouse and Distribution) Licence Applications & Compliance
Comprehensive Pharmaceutical Licensing & Regulatory Compliance:
We manage the complexity of securing and sustaining all mandatory pharmacy licences—spanning retail, manufacturing, distribution, warehousing, and wholesale operations. Our comprehensive, end-to-end service guarantees your business maintains unwavering adherence to all stringent requirements established by the regulatory authority.
Medical Device Applications & Licensing
Medical Device Registration and Market Authorisation:
Entrust us with the full regulatory lifecycle management for your medical devices. We expertly prepare, submit, and manage all necessary documentation to secure official licensing and registration, ensuring complete compliance with requisite safety, quality, and efficacy standards for swift market entry.
Legal Representative Services with SAHPRA
Official Legal Representative Services (SAHPRA Liaison):
For international organisations, we serve as your official and fully accountable Legal Representative before the South African Health Products Regulatory Authority (SAHPRA). We function as the primary local liaison, managing all submissions, official communication, and legal compliance obligations on your behalf within the jurisdiction.
API Distribution
Active Pharmaceutical Ingredient (API) Supply Chain Management:
We facilitate the secure, reliable, and fully compliant supply chain for your Active Pharmaceutical Ingredients (APIs). Our service ensures the raw materials critical for your product manufacture are ethically sourced, delivered promptly, and managed under the highest standards of quality control and Good Distribution Practice (GDP).
Sieve Distribution
Active Pharmaceutical Ingredient (API) Supply Chain Management:
We facilitate the secure, reliable, and fully compliant supply chain for your Active Pharmaceutical Ingredients (APIs). Our service ensures the raw materials critical for your product manufacture are ethically sourced, delivered promptly, and managed under the highest standards of quality control and Good Distribution Practice (GDP).
Complementary Medicines, Nutraceuticals, Health Products etc,
Regulatory Affairs for Complementary Medicines & Nutraceuticals:
Navigate the distinct regulatory requirements for your health and wellness portfolio with precision. We manage the official registration, quality assurance, and ongoing compliance for complementary medicines, nutraceuticals, vitamins, and health supplements, ensuring your product range is legally authorised and market-ready.
Interim Responsible Pharmacist and Deputy Responsible Pharmacist Services
Interim Responsible Pharmacist (RP) and Deputy RP Provision:
We ensure absolute business continuity and legal supervisory compliance by providing highly qualified, interim Responsible Pharmacist (RP) and Deputy Responsible Pharmacist (DRP) personnel. We fill these essential, legally-mandated roles during transitional periods, guaranteeing uninterrupted regulatory oversight.