Quality, Expertise, Global Success.
Amber LifeSciences is a globally trusted provider of high-quality, affordable generic medicines and services, including CMO, CDMO, CRO, and Loan Licensing. Accredited by WHO-GMP, USFDA, EUGMP, and TGA, we ensure a reliable supply, competitive pricing, and regulatory expertise across international healthcare markets.
Global Reach, 25+ Products, Seamless Approvals!
Amber LifeSciences offers an extensive portfolio of over 25 product types and formulations, supported by comprehensive regulatory expertise to ensure a smooth approval process for healthcare products worldwide.
Tablets
Capsules
Lotion
Injection
Eye Drops
Inhaler
Human Albumin
Ointments
Syrup
Nasal Sprays
Infusion
Biological
Global Regulatory Expertise for Seamless Registration
Amber LifeSciences dedicated Drug Regulatory Affairs team collaborates with you worldwide, offering comprehensive documentation and guidance for product registration. Trust us for expert support and a smooth, hassle-free journey to global regulatory clearance.
50+ Exporting
Countries
7000+ Product
Lines
500+ Clients
Globally
500+ Ready
Dossiers
Why Choose Amber LifeSciences?
Amber LifeSciences delivers expert regulatory services that ensure pharmaceutical products meet global standards seamlessly. Our dedicated team provides end-to-end support, focusing on quality, efficiency, and compliance across international markets.
CTD and ACTD Dossiers
Complete documentation for global regulatory submissions.
Essential Certifications
Free Sale Certificate (FSC) and Certificate of Pharmaceutical Product (COPP) for global distribution and approval.
Bioequivalence (BE) Studies
Supporting product approval with essential data and reports.
Product Samples & Analysis
Providing samples, Certificate of Analysis (COA), and product verification for registration.
Post-Approval Support
Ensuring continued regulatory adherence with ongoing support.
Regulatory & Consultation
Expert guidance and tailored documentation for country-specific requirements.
“Global Reach, Local Impact in Healthcare!”
Amber LifeSciences operates across Africa, Asia, America, Europe, and Oceania, delivering high-quality pharmaceuticals tailored to regional needs. Our integrated services support drug development success, offering end-to-end solutions from early-stage development to commercial production for global pharmaceutical partners.
Africa
America
Asia
Europe
Oceania
Our Pioneering Manufacturing
Pioneering manufacturing solutions for pharmaceutical excellence and reliability.