Amber LifeSciences: Your Strategic CDMO Partner!
Amber LifeSciences streamlines the journey from drug discovery to commercialization. As a strategic CDMO partner accredited by WHO-GMP, USFDA, EUGMP, and TGA, we provide end-to-end support, risk mitigation, and strong project management, ensuring a smooth path to market.
25+ Product Range with Regulatory Support
Amber LifeSciences, a leading CDMO, offers over 25 product types and formulations. Our comprehensive regulatory support guarantees a seamless approval process, enabling you to confidently bring your healthcare products to market.
Tablets
Capsules
Lotion
Injection
Eye Drops
Inhaler
Human Albumin
Ointments
Syrup
Nasal Sprays
Infusion
Biological
Expert Regulatory Guidance for Product Registration
As your trusted CDMO partner, Amber LifeSciences offers expert regulatory guidance throughout the registration process. Our dedicated Drug Regulatory Affairs team collaborates with you to provide all essential documentation and support, ensuring a hassle-free path to regulatory clearance for your products. Rely on us for seamless navigation of compliance, empowering your success in the market.
50+ Exporting
Countries
7000+ Product
Lines
500+ Clients
Globally
500+ Ready
Dossiers
Why Choose Amber LifeSciences as Your CDMO?
Amber LifeSciences stands out as your ideal CDMO partner, offering expert regulatory services that ensure your pharmaceutical products effortlessly meet global standards. Our dedicated team provides comprehensive, end-to-end support, prioritizing quality, efficiency, and international compliance to help you succeed in the competitive market.
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.
Let’s Collaborate on Your Next Breakthrough – Connect with Amber
Fill the Form for Expert CDMO Support. Let’s Talk!
Accelerate Drug Development with Amber CDMO.
Choose Amber LifeSciences CDMO for Efficient, Reliable Drug Development and Innovation.
24/7 Fast Support
Experience 24/7 fast support with our dedicated and reliable CDMO services.
FREE Web-Consultation
Get FREE Consultations and Expert support from our dedicated CDMO services.
What expertise do CDMOs provide for development?
CDMOs provide technical expertise in drug formulation, analytical development, regulatory support, and quality control, ensuring a comprehensive approach to bringing pharmaceutical products to market.
How do CDMOs help manage production costs?
CDMOs leverage their expertise and economies of scale to optimize processes, reduce waste, and help clients effectively manage the costs associated with drug development and manufacturing.
What solutions address capacity constraints from CDMOs?
CDMOs offer flexible manufacturing capabilities to help pharmaceutical companies meet demand when they lack the internal capacity for large-scale production.
How do CDMOs ensure regulatory compliance?
CDMOs assist in navigating the complex regulatory landscape by providing expertise in quality, safety, and efficacy, ensuring that products meet all necessary compliance requirements.
How do CDMOs accelerate time to market?
CDMOs streamline the drug development and manufacturing process by utilizing their experience, advanced equipment, and optimized workflows, thereby reducing approval timelines and accelerating time to market for new products.
About Us
Discover the story and mission driving AmberLifeSciences forward.