Committed to Quality Services
Guided by over 25 years of expertise in pharmaceutical science, we deliver innovative clinical development, regulatory and post-market surveillance services, all tailored to meet the unique needs of our clients. Our mission is to advance global health through collaboration, expertise, and integrity. By leveraging our robust network across America, Europe, and Africa, we provide streamlined services that address regulatory challenges, foster innovation, and ensure compliance with the highest quality standards. We are a trusted partner that empowers organizations to succeed at every stage of the product lifecycle. Together, we strive to create a world where essential health interventions are accessible to all.
What we do
Clinical Research and Operations
Our Clinical Research and Operations service is designed to streamline the clinical trial process, ensuring precise execution and compliance across all phases.
With a team of experts proficient in protocol development, site selection, and patient recruitment, we aim to make every trial successful. Our approach includes, but not limited to data management and analytics, monitoring, and medical writing services, providing a full spectrum of support from study startup to close-out.
Project Management
Our Project Management team is dedicated in orchestrating every phase of your clinical development journey.
From strategic planning to day-to-day operations, we manage timelines, budgets, and resources to ensure project milestones are achieved without compromising quality, or compliance. Our project managers act as central point of communication to foster transparency, allow quick decision-making and regulatory standards alignment along with clinical operations. We deliver projects on time and within scope, allowing sponsors to focus on core objectives while we handle the complexities of clinical project management.
Real Life Data generation
We provide robust Real-world data insights to optimize patient’s outcome supporting market approvals and the broader healthcare impact of new therapies.
Our epidemiologists and data scientists work collaboratively to design and implement studies that capture real-world data, helping clients make evidence-based decisions that support market access, regulatory approval, and post-marketing commitments. Using advanced data analytics, we provide actionable insights demonstrating effectiveness, safety, and cost-efficiency of healthcare interventions.
Regulatory Affairs
Navigating regulatory landscapes for successful product launch
Our Regulatory Affairs team simplifies the regulatory pathway for new products, working closely with regulatory agencies to improve operational efficiency and effectiveness. From regulatory strategy development to dossier preparation and submission, our experts ensure all documentation aligns with global and regional requirements. By partnering with regulatory bodies, we proactively address compliance issues, helping you bring innovative products to market faster.
Drug and Vaccine Safety
Drug safety is at the core of patient care, and our Pharmacovigilance services ensure your products meet the highest safety standards throughout its lifecycle.
We provide comprehensive safety solutions, including adverse event reporting, signal detection, safety risk management, safety data analysis, pharmacovigilance systems and QPPV services. With a focus on patient safety and regulatory compliance, we help clients fulfill their pharmacovigilance obligations, protect public health, and maintain product trust.
Quality and Compliance
We help setup a Quality Management System and provide audit and compliance services to ensure adherence to good practices (GCP, GLP, GMP and GSDP).
Our team conducts comprehensive audits to identify compliance gaps, offering actionable recommendations that bolster quality assurance throughout your operations. From facility inspections to system audits and supplier assessments, we ensure that every aspect of your projects meets regulatory and ethical standards. Our commitment to Good Practices compliance helps clients avoid regulatory setbacks and uphold the integrity of research processes.
Pharmaceutical Policy and Regulation
We assist clients in navigating complex regulatory frameworks across global markets.
Our experts stay abreast of evolving regulations to effectively guide your development and compliance strategies. We support regulatory policy interpretation, market access strategies, and stakeholder engagement to ensure your product’s compliance at every stage. By addressing policy changes proactively, we help clients mitigate risks, streamline compliance, and enhance their operational efficiency in the highly regulated pharmaceutical landscape.
Our leadership team
We Excel through a strategic leadership of 80 cumulative years in the set up and the management of programs that resulted in innovative biopharmaceutical solutions for communities across regions
Joachim Doua
M.D., CEO, Medical OfficerJoachim Doua
Joachim has over 20 years of experience in global health. Joachim held different roles and leadership positions in global industry. As Director, Clinical Development Physician and member of various R&D Committees he played a pivotal role in the development and life cycle activities of vaccines and monoclonal antibodies. Joachim also served various organisations and public institutions including WHO, EU Commission, USAID, CEPI, EDCTP3, EMA.
Dee Carnegia
B.Sc., MBA, Training ConsultantDee Carnegia
Dee is an accomplished, top-performing global Clinical Operations Executive with demonstrated history of leading diverse projects across diverse therapeutic areas in pharma, biotechnology, and device industry. With over 20 years of experience, Dee has overseen global study management and execution of all development phases, strategic planning, CRO/Vendor, budget, quality and risk management and inspection readiness. She has contributed to bring innovative therapies and vaccines to market for patients’ unmet needs.
Maryrose Petrizzo
B.Sc., MBA Lead, Quality Systems ManagementMaryrose Petrizzo
Maryrose is a GCP Quality Professional with over 25 years experience for drugs, biologics, and medical devices. Balancing the letter and spirit of the law with business needs, Maryrose has provided services in GCP audits, inspection readiness activities, risk management, Quality systems development, Risk Management and Vendor Oversight, and clinical due diligence.
Loni Mendez
B.Sc., MBA, Grant Acquisition LeadLoni Mendez
Loni Mendez is a highly recognized and sought-after Expert in the business community where she brings over 20 years of corporate human resources and consulting experience with global organizations. Loni served as writer for grants ranging from dozen hundreds to millions USD with a wide range of organizations. She was awarded Local Businessperson of 2022 & 2023 Year Awards by Alignable.com.
Hanneke J.C. Dominicus
MD, M.Sc., Consultant, Business strategyHanneke J.C. Dominicus
Hanneke has over 25 years of experience. She’s been senior Regulatory Assessor in Drug safety and Risk Management for EMA and a core member of the Pharmacovigilance Rapid Response Group for the H1N1 pandemic flu vaccines approval and deployment in 2009. As a Policy maker for the Dutch Ministry of Health, Hanneke provided consultations on vaccines to pharma companies, public health institutions, and NITAGs. Hanneke is an accomplished Benefit-Risk physician.
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