1. Pharmaceutical, Medical Devices, Laboratory Equipment and Reagents Regulatory Affairs Services
Prodigy Healthcare’s regulatory affairs consultants assist companies to plan and manage their pharmaceutical and medical product development programs and regulatory requirements.
To speed-up market access for your medicinal Can we use healthcare instead of medicinal? products you need to ensure strict adherence to all regulatory requirements. Our regulatory affairs services help you explore the shortest route and timeframe to put your products on the market safely (or in a regulatory compliant way)
Pharmaceutical Regulatory Affairs Services:
- Dossier/submission preparation or review and filing
- Regulatory classification of products across different jurisdictions
- Follow-up until complete registration with the regulator
- Follow-up of Laboratory testing
- Smooth transition of Local Technical Representative (LTR) mandate to distributor of choice
- Provision of LTR service in event the Marketing Authority Holder (MAH) would like multiple importers/distributors
- Development of regulatory strategy for the product’s life cycle
- Facilitate interaction with regulatory agencies, such as in meetings and conference calls, negotiations during development stages, submissions and submission approval process
- Liaison with regulatory agencies on regulatory, Chemistry, Manufacturing and Controls (CMC), clinical and toxicology matters
- Respond to regulatory agency questions
- Consultancy on medicinal products in development, generics, biosimilars, bibliographic submissions and orphan drugs
- Strategic regulatory advice
- Post Registration support with Pharmacovigilance and compilation of Periodic Safety Update Reports (PSUR) from the market
2. Healthcare Business Strategy, Sales and Marketing
Prodigy Healthcare has on staff a number of industry seasoned business strategy executives who have led organizations through tough and challenging business issues involving Business Strategy, Sales and Marketing issues. These business strategy executives are available to help you across a number of difficult issues across the following topics:
Market definition; market sizing and growth analyses; competitive analyses; strategic process management
Sales organization; sales compensation and rewards; sales tools and support; sales recruiting, training and coaching
Marketing strategy; product marketing; marketing communications; marketing effectiveness; market research
3. Warehousing and Distribution
Prodigy Healthcare is an importer, exporter and distributor of quality healthcare supplies. We were the first W.H.O Good Distribution Practices certified company in Kenya, assuring you of the quality and integrity of our products from the manufacturer right to our client.
– We will handle the whole works from ‘ex-works’ factory to ‘landed’ Kenya
Warehousing of Medical Devices under GDP for Kenya
– Temperature and humidity monitored, high security with CCTV surveillance and secure access & GDP Certified.
– Our GDP certified warehouse is approved for Class A, Class B, Class C & Class D risk classes of medical devices which may include single-use sterile, single-use non-sterile, re-usable medical devices, single-use contact lenses, re-useable opthalmic devices, re-useable medical devices, electro-mechanical equipment or medical devices, medical device class consumables
Warehousing of Pharmaceuticals, Biologics & Bio-similars for Kenya
- Cold chain toolkit for proper management of cold chain products from reception to distribution to the end user
- Refrigerated storage (2-8 Deg C), humidity controlled storage for pharmaceuticals, biologics & biosimilars
- Temperature and humidity monitored, high security with CCTV surveillance and secure access & GDP Certified.
– Local logistics within Kenya – to clinics, hospitals & pharmacies.
– Ability to export to any country in Africa with the proper documentation and packaging for regular and cold chain products
Invoicing & AR (Accounts Receivables)
Multiple working models are available:
– Invoicing under your company name
– Invoicing through Prodigy Healthcare Limited
– Separate database for own company invoicing available. The software can also be enabled for online access anywhere in the world to facilitate invoicing by own company and printing in Prodigy Office
Medical Device Importer, Dealer, Storage in Kenya
– We can help your company Import, Store / Warehouse, Distribute ALL CLASSES of medical devices for Kenyan market
Set-up & management of YOUR OWN GDP warehouse in Kenya
– We are able to set-up and manage a new GDP warehouse for your company under a turnkey project management basis and handover the completed project to your company. This will save you time and alleviate the set-up difficulties for your company and allow your staff to focus on what you do best.
– we will enable you set up a Pharmacy and Poisons Board compliant facility for successful premise licensing
Named-Patient-Basis Import of Medicine and Orphaned-Drugs Import for Kenyan Market
– We can source and supply of specialty medicines under Special Access Program. We have a strong network that offers cost advantages and stability of supply to our customers.
- Wholesale / Distribution: Branded Generic & Specialty Medicines
- Market Shortages, Unlicensed / Unregistered Medicines
- Named Patient / Compassionate Procurement /Emergency Healthcare needs
Bonded Warehouse: Import for Re-Export of Medicine and Orphaned-Drugs
– We can help source & import and re-export medicines or orphaned drugs for Regional Countries
– The bonded warehouse can be used for products in-transit to other countries, even though the products are not registered in Kenya