Pharma & Biotech

As the Pharma & Biotech industry grows in Africa, BIOSCIGEN provides tailored Scientific and Regulatory Advisory and Vigilance Services to help your innovations succeed in this complex and dynamic market.

Scientific and Regulatory Advisory

Bridging Innovation and Compliance Across Africa

Pharma and biotech companies frequently encounter a range of regulatory challenges when navigating the diverse and intricate regulatory landscape across Africa. These challenges can lead to delays, increased costs, and complexities that hinder market entry. BIOSCIGEN simplifies this process by offering expert regulatory advisory services tailored to the African context.

We provide comprehensive support to ensure compliance with local regulations, navigate the bureaucratic maze, and address any obstacles that may arise. By leveraging our expertise, companies can expedite their market entry, reduce risks, and achieve a smoother, more efficient path to bringing their products to African markets.

Our Scientific and Regulatory Advisory Services

Regulatory Strategy Development: Tailored strategies for market entry and compliance, considering the unique regulatory landscapes of African countries.
Regulatory Submissions: End-to-end support in preparing and submitting dossiers, with a focus on speeding up approval timelines.
Clinical Trial Management: Expertise in designing and managing clinical trials that comply with local regulations and international standards.
Product Classification and Registration: Assistance in classifying and registering products across various African markets, ensuring a smooth approval process.
Labelling and Packaging Compliance: Ensuring that your products meet all local labelling and packaging requirements, which are often diverse and complex across the continent.

Why Choose BIOSCIGEN?

Partnering with us means gaining access to local regulatory knowledge and networks. We are committed to overcoming the unique challenges of the African market, ensuring that your products are compliant, safe, and ready for distribution.

Vigilance Services

Ensuring Product Safety and Compliance Post-Market

In the Pharma & Biotech industries, vigilance is crucial for maintaining safety and ensuring regulatory compliance. It involves ongoing monitoring and evaluation of products to identify and address potential risks or adverse effects. In Africa, where regulatory environments can be complex and diverse, managing these risks effectively becomes even more challenging. BIOSCIGEN addresses these challenges by offering comprehensive Vigilance Services tailored to the African market.

Our services include proactive risk management, thorough adverse event reporting, and continuous safety monitoring. By partnering with us, companies can ensure robust compliance, safeguard their products, and protect patient safety throughout their operations in Africa.

Our Vigilance Services

Pharmacovigilance: Continuous monitoring of the safety of pharmaceutical products, with a focus on adverse event reporting and risk management.
Regulatory Updates: Keeping you informed of any changes in regulatory requirements across African countries, so your products stay compliant.
Risk Management: Developing and implementing risk management plans that consider the specific challenges and opportunities in the African market.

Why BIOSCIGEN is Your Ideal Partner?

Our deep understanding of the African healthcare ecosystem allows us to offer Vigilance services that are both comprehensive and tailored to the continent’s unique needs. We help you protect your brand reputation by ensuring your products remain safe and compliant throughout their lifecycle.