Maira Labs specializes in facilitating the seamless Transfer of Technology for Active Pharmaceutical Ingredients (APIs), bulk drugs, and their intermediates. By partnering with clients who have developed proven processes and technologies, Maira Labs ensures a smooth transition to large-scale production while strictly adhering to regulatory and patent requirements. Our approach emphasizes non-infringement of intellectual property, providing a secure and compliant pathway to scale up production efficiently.
Our Technology Transfer services encompass :
- Process Validation: Ensuring that the transferred process meets all quality and operational standards.
- Regulatory Compliance: Aligning production with global regulatory frameworks such as cGMP and USFDA standards.
- Training and Support: Comprehensive onboarding and training for manufacturing teams to ensure process continuity.
- Custom Solutions: Tailored approaches to match the unique needs and infrastructure of each client.
By leveraging expertise in process development and our network of certified facilities, Maira Labs ensures a reliable and efficient Tech Transfer process, helping clients optimize production and reduce time-to-market.