At Xcene Research, our Market Access and Regulatory Affairs Division provides a fully integrated, science-driven framework that supports pharmaceutical, biotechnology, and medical device companies throughout the complete product lifecycle from Investigational New Drug (IND) and Clinical Trial Application (CTA) submissions to Marketing Authorization (MAA), pricing, reimbursement, and distribution.
As Africa’s healthcare ecosystem evolves into a frontier for innovation, Xcene Research bridges the critical gap between scientific discovery and equitable patient access. Our expertise lies in designing regulatory and access pathways tailored to Africa’s emerging markets, where speed, adaptability, and compliance must coexist.
We help both locally developed and internationally approved therapies navigate diverse national frameworks and fast-track routes to market, ensuring that sponsors achieve timely product registration and sustainable access. By combining deep regulatory intelligence, real-world data, understanding of the patient journey, and local partnerships, we accelerate the availability of novel treatments across Sub-Saharan Africa’s expanding clinical and commercial landscape bringing strategic vision to life.
Our commitment is to transform innovation into impact ensuring that every product developed or introduced through our network reaches the patients who need it most, safely, swiftly, and sustainably committed to leaving no patient behind.
How Xcene Research Delivers Market Access Across Africa’s Emerging Markets
Product Entry and Market Authorization
Africa’s emerging pharmaceutical landscape represents one of the most promising frontiers for global product expansion and patient access. At Xcene Research, we provide a comprehensive product-entry and registration framework that enables pharmaceutical, biotechnology, and medical device companies to achieve regulatory approval, market access, and distribution across Sub-Saharan Africa through scientifically rigorous and compliant processes.
Our Regulatory Affairs and Clinical Development experts combine an in-depth understanding of stringent regulatory authority (SRA) requirements such as those of the FDA, EMA, and MHRA with extensive operational experience across African national regulatory agencies, including NAFDAC (Nigeria), Ghana FDA, TMDA (Tanzania), PPB (Kenya), and other regional bodies under ECOWAS, EAC, and the African Medicines Agency (AMA).
We support sponsors in designing localized registration strategies, conducting required bioequivalence studies, and preparing fit-for-purpose dossiers that meet both scientific and regulatory expectations.
Preparation and submission of Marketing Authorization Applications (MAA) under CTD and ACTD formats.
- Bioavailability/Bioequivalence (BA/BE) studies conducted in Xcene’s dedicated, GCP- and GLP-compliant facilities to meet regulatory registration requirements for generics and reformulated products.
- Bridging and adaptation of international data packages for local or regional submissions.
- Regulatory fast-track and reliance mechanisms for accelerated market entry.
- Labeling, serialization, and pharmacovigilance registration for post-approval compliance.
- Lifecycle management, renewals, and post-market variations.
- Strategic coordination with ministries of health, procurement agencies, and regulatory authorities to enable early access and supply readiness.
Xcene Research develops regulatory alignment and market-entry strategies for products already approved by SRAs that seek registration and commercialization across African markets.
We facilitate dossier adaptation, bridging bioequivalence protocols (where required), and regulatory fast-track recognition procedures, allowing sponsors to enter markets without duplicative clinical studies.
Our integrated approach ensures that both new and established therapies reach African patients faster, supported by strong regulatory compliance, validated bioanalytical data, and sustainable access pathways.
By combining regulatory intelligence, bioequivalence science, and local partnership networks, Xcene Research accelerates product fast-track to market ensuring that innovation, quality, and access converge to strengthen healthcare systems across Africa’s emerging economies.
Post-Clinical Trial Market Access Commitment
At Xcene Research, clinical development marks the beginning of our commitment and not the end. We recognize that the ultimate measure of success is not study completion but patient access and health impact. Our post-clinical trial access model is designed to transform investigational success into sustainable, real-world availability through scientific, regulatory, and economic integration.
Our approach combines regulatory transition planning, health-technology assessment (HTA) preparedness, and real-world data (RWD) generation, ensuring that products evaluated in Africa continue to deliver value long after the trial concludes.
Our Post-Trial Support Includes:
- Transitioning IND/CTA products to full marketing authorization
- Regulatory dossier development using local data
- Real-world evidence and patient registry creation
- Pricing, access, and reimbursement strategy alignment
- Collaboration with ministries, payers, and advocacy groups for uptake
- Manufacturing localization and technology transfer advisory
This full-spectrum model ensures that products developed or tested in Africa remain accessible in Africa, advancing health equity and sustainability.
Complementary Market Access Services
While Product Entry and Post-Clinical Trial Market Access form the core of Xcene Research’s regulatory and scientific support model, we recognize that sustainable access requires more than approval, it demands affordability, policy integration, and supply continuity.
To this end, Xcene Research offers a suite of complementary market access services designed to ensure that therapies, whether locally developed or internationally licensed, achieve real-world uptake and long-term sustainability across Africa’s emerging markets.
Our complementary services integrate health economics, government engagement, and distribution infrastructure, creating a unified pathway from market authorization to patient delivery.
How Xcene Research delivers:
Pricing, Reimbursement & Health Economics
To complement regulatory success, Xcene Research delivers value-based pricing and reimbursement strategy support that reflects Africa’s diverse healthcare and payer environments.
Our team applies Health Economics and Outcomes Research (HEOR), Health Technology Assessment (HTA), Cost Effectiveness Analysis and Budget Impact Analysis (BIA) to demonstrate clinical and economic value, support payer negotiations, and promote equitable access.
Core Capabilities:
- Development of pricing and reimbursement dossiers
- Cost-effectiveness and budget-impact analysis
- Value demonstration and stakeholder engagement
- Price benchmarking and reference pricing across markets
- Managed-entry and risk-sharing agreement design
Post-Trial Integration:
We facilitate the inclusion of innovative therapies into national formularies, essential medicines lists, and donor-funded programs, ensuring that regulatory approvals translate into tangible patient access and reimbursement support.
Government & Subsidized Access Programs
Xcene Research collaborates with government agencies, NGOs, and global health institutions to design policy-aligned, equitable access programs for essential medicines and advanced therapies.
We help sponsors integrate their products into national reimbursement schemes, public–private partnerships (PPP), and subsidized procurement systems that lower financial barriers for patients.
Our Expertise Covers:
- Mapping of public procurement and reimbursement frameworks
- Tiered pricing and co-payment model development
- Inclusion of products in national and donor-funded supply chains
- Quality assurance and pharmacovigilance for subsidized therapies
- Engagement with health policy and technical working groups for access advocacy
These collaborations enable sustainable scaling of innovation, supporting governments and donors in achieving Universal Health Coverage (UHC) and health equity goals.
Drug Distribution & Commercial Access
As part of our holistic market access ecosystem, Xcene Research provides strategic and operational oversight for compliant drug distribution and commercialization across Sub-Saharan Africa. Through partnerships with Xcene Pharmaceuticals, certified distributors, and logistics providers, we enable secure, efficient, and GDP-compliant delivery from import to last-mile access.
Distribution Support Includes:
- Import permit guidance, warehousing, and controlled-substance management
- Partnership facilitation with licensed distributors and wholesalers
- Establishment of regional depots and last-mile logistics infrastructure
- Good Distribution Practice (GDP)-compliant storage and temperature control
- Integration with pharmacovigilance and post-market surveillance programs
This ensures that every approved therapy moves safely from authorization to delivery, reaching patients across both public and private healthcare systems.
Together, these complementary services position Xcene Research as a true end-to-end partner for Market Access in Africa, combining scientific excellence, regulatory agility, and on-the-ground infrastructure to accelerate the journey from innovation to impact.
Our Strategic Framework for Market Access
- Integrated Expertise
Xcene Research unifies regulatory science, clinical operations, health economics, and commercial strategy within one coordinated framework delivering scientific rigor, operational precision, and speed from submission to market launch. - Local Relationships, Global Compliance
Through sustained engagement with regulators, ministries of health, and payers across more than 25 African markets, we align local execution with ICH, WHO, EMA, and FDA standards, enabling regulatory predictability and fast-track entry pathways. - Implementation Science & Capacity Building
At Xcene Research, we recognize that regulatory success must translate into measurable patient outcomes. Through our Implementation Science pillar, we ensure that evidence-based interventions move seamlessly from policy to practice.
We achieve this by:
- Building capacity among healthcare professionals through targeted training on treatment guidelines, pharmacovigilance, and real-world data utilization.
- Collaborating closely with patient advocacy organizations, ensuring patient perspectives shape implementation priorities.
- Partnering with ministries of health and professional societies to institutionalize evidence-based care across public and private sectors.
- Conducting implementation-effectiveness research to evaluate adoption, reach, and sustainability of new interventions in African health systems.
This model ensures that every innovation we help deliver doesn’t end with approval—it reaches patients, strengthens systems, and delivers measurable health outcomes.
- Discovery
- →
- Clinical Trials
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- Market Authorization
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- Implementation Science
- →
- Sustainable Access
4. Regional Infrastructure
With a strong footprint across Sub-Saharan Africa and integrated entities, Xcene Laboratories, Xcene Pharmaceuticals, and Xcene Research, we deliver a complete market access ecosystem from submission to post-market distribution, ensuring compliance, quality, and scalability.
— Adebukunola Telufusi, CEO, Xcene Research
