Regulatory Affairs Consultancy
Africa is world’s second fastest growing pharmaceutical market. Our regulatory affairs profesisonals have substantial knowledge of the various regulatory guidelines and regulation in Africa with a special focus in French speaking countries in West and Central Africa. We offer regulatory affairs support on a wide range of products including New Chemical or biological Entity, Generics or Biosimilars, Medical Devices, Traditional Medicine, Veterinary products...
Product registration
It can be challenging for a company to register a drugs in the continent as the regulatory framework present some specifities and differ from India, Asia, Europe or the USA with most of the time little or no integration between approval mechanisms. We will support you in the:
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Preparation of a Regulatory Development Plan
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Advise on regulatory strategies and regulatory pathway optimization
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Development, review and submission of a complete Marketing Authorization Application (MAA) following the Common Technical Document (CTD) format for all type of product including generic and medical devices
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Preparation and review of patient information leaflets
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support regulatory labeling (regional labeling)
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Assistance in organizing a scientific advise meeting with the Regulatory authorities
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Review of promotional and advertising material to ensure that they comply with all the relevant National Medicine Regulatory Authorities requirements.
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Support in themaintenance of the product life cycle
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Application and processing of import permit
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Provision of regulatory and administrative support for procurement of commodities from internal and external sources
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Custom Clearance services
Market access
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Market access strategy
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Full consultancy support for the development and implementation of your market access strategy
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Market assessment
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Evaluation of market opportunities using both primary and secondary data. through our network of clinicians, procurement managers and other healthcare professionals to identify an appropriate cohort of interviewees and then ask the right questions to accurately assess and analyse the opportunity.
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Company Registration in any of the west and Central African countries
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Identification and screening of local distributor or potential company representatives
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We will link you with our extensive network of product distributors and local companies in West and Central Africa
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Post-marketing drug safety surveillance
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Pharmacovigilance System setup and maintenance
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Creation and maintenance of Pharmacovigilance System Master File (PSMF)
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Compliance of the PV system
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LPPV – Local Person Responsible for Pharmacovigilance
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Provision of a Local Qualified Person for Pharmacovigilance Service (LQPPV)
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Pharmacovigilance Translations to/from Local Languages.
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Local ICSR Management.
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Safety mailbox management.
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Local case submission.
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Case follow-up.
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Preparation or review of Safety Reports
