Services Offerings – Blue Sky Bio Labs

Contract Laboratory Services

Provide GMP and GLP contract laboratory services to support the development of drugs, biologics, and cellular therapies.
Equipped with ISO 5, ISO 7, and ISO 8 certified laboratories, we offer flexible, scalable solutions that can be tailored to meet the unique needs of biologics, drugs, and other therapeutic innovations through strategic partnerships.

Cutting-edge R&D support for the discovery and development of drugs, biologics, and cellular therapies.
Advanced product formulation and process development.
Scientific support for novel drug delivery systems and biologic therapies.
Development of robust research protocols tailored to your specific product needs.
Expertise in optimizing processes to accelerate product innovation and development.
Prototyping and formulation for innovative drugs and biologics.
Process optimization for improved efficiency and scalability.
Stability studies and accelerated aging tests for shelf-life determination.

Expert guidance on protocol development.
Comprehensive support for IND, BLA, NDA, and ANDA applications.
Strategic guidance to navigate complex regulatory landscapes with confidence.
Expertise in FDA, EMA, and global regulatory compliance for drugs, biologics, and combination products.
Support with submissions, audits, and meeting regulatory milestones effectively.
Specialized assays and services to support product development and approval.
Strategic planning for Investigational New Drug (IND) and Biologics License Application (BLA) submissions.