Tailored Life Sciences Solutions for Successful Market Entry and Compliance in Africa
End-to-End Regulatory and Vigilance Support for the Life Sciences Industry
At BiosciGen, we simplify complex regulatory pathways and safety monitoring systems, empowering innovators to bring safe, effective, and compliant products to African markets.
Scientific & Regulatory Advisory Services
We help companies navigate complex regulatory requirements, from early product development through market authorization. Our advisory services are designed to accelerate approvals, strengthen documentation quality, and maintain compliance with both global and local regulatory frameworks.
Key Objectives:
Streamline submission and approval processes
Enhance documentation quality and consistency
Facilitate transparent communication with local authorities
Support scientific and ethical excellence in product development
Our Key Regulatory Services
1. Regulatory Strategy and Planning
We design tailored regulatory strategies aligned with each country’s requirements to support efficient product registration and market entry.
Includes: market entry analysis, regulatory pathway mapping, and dossier planning.
2. Regulatory Submissions
Preparation, compilation, and submission of regulatory documentation in line with national guidelines and recognized international formats such as CTD and eCTD.
3. Compliance Support
We support ongoing compliance with applicable regional and international regulatory standards, including country specific frameworks and recognized global guidance.
4. Clinical Trial Regulatory Support
Guidance across the clinical trial lifecycle, including protocol and regulatory documentation review, ethics and authority submissions, and support aligned with Good Clinical Practice principles.
5. Documentation and Dossier Management
Preparation, review, adaptation, and lifecycle maintenance of regulatory dossiers, technical files, labeling, and supporting documentation across product categories.
6. Local Technical Representation (LTR)
We act as or support the Local Technical Representative where required, serving as the regulatory point of contact with national authorities and ensuring local presence, communication, and compliance obligations are met.
7. Regulatory Intelligence and Monitoring
Ongoing monitoring and interpretation of regulatory updates, policy changes, and guidance issued by African regulatory authorities to support proactive compliance and informed decision making.
How You Benefit
Faster market access through strategic planning
Reduced regulatory risks and submission delays
Tailored strategies for each African regulatory environment
Dedicated scientific and compliance expertise at every stage
Vigilance Services
BiosciGen’s vigilance services ensure the continued safety, quality, and performance of products throughout their lifecycle. Our approach combines global standards with deep local expertise to build robust post-market surveillance and reporting systems across Africa.
Our Vigilance Framework Covers:
Pharmacovigilance – For medicines and vaccines
Materiovigilance – For medical devices and diagnostics
Cosmetovigilance – For cosmetics and personal care products
Nutrivigilance – For dietary supplements and nutraceuticals
Veterinary Vigilance – For animal health products
Our Vigilance Solutions
1. Pharmacovigilance (PV)
We establish, manage, and maintain PV systems for local and global clients, ensuring compliance with national and international requirements (ICH, GVP, WHO).
Services include: Individual Case Safety Report (ICSR) management, signal detection, aggregate reporting (PBRER, DSUR), and risk management planning.
2. Medical Device Vigilance
Monitoring and reporting of device-related adverse events, trend analysis, and corrective action follow-up in accordance with local and ISO 13485 standards.
3. Cosmetovigilance
Safety surveillance for cosmetic products, including incident collection, causality assessment, and periodic reporting aligned with national authority expectations.
4. Nutrivigilance
Post-market surveillance for dietary supplements and nutraceuticals, focusing on safety signals, labeling compliance, and consumer health protection.
5. Veterinary Vigilance
Monitoring and managing adverse events associated with veterinary pharmaceuticals and vaccines, ensuring animal and human safety.
Vigilance System Setup and Maintenance
We design and implement full vigilance systems customized for your product type and market presence:
Local Qualified Person for Pharmacovigilance (LQPPV) setup and oversight
PV Standard Operating Procedures (SOPs) and safety database implementation
Case intake and triage systems for African regulatory environments
Audit readiness and inspection support
How You Benefit
Reliable compliance with local vigilance reporting timelines
Transparent communication with regulators and health authorities
Reduced safety risks and proactive detection of adverse events
Integrated systems for multi-country operations across Africa