Services

Pharmaceutical

We provide quality services to various Pharmaceutical clients in the following areas:

Pharmaceutical Development

We provide Pharmaceutical/Bio-Pharmaceutical development services to meet our client's needs.

• Custom synthesis, manufacturing and sourcing of regulatory starting materials, key intermediates, special synthones, and APIs from mg to kg scale.
• Large scale manufacturing utilizing special equipment (Cryogenics, Hastelloy, High Pressure) under cGMP at associated sites.
• Synthesis of compound libraries data mining and bioinformatics capabilities.
• Pharmaceuticals and ingredients related analysis.

 

Regulatory Compliance, Submissions and Approvals

We partner with our clients to usher them through Regulatory Compliance, Submissions and Approvals to accelerate bringing tomorrow's medicines to markets worldwide.

• Science based innovative regulatory strategy and compliance guidance from Phase 1, 2, 3 and post approval (IND-NDA-Post-Approval)
• Planning, preparation and management of regulatory submissions following general and country specific guidelines (CTD, ICH) for US-FDA, EMEA, HC, ANVISA, TGA, MHLW and ROW approvals.
• We develop innovative strategies and Science based innovative QbD based regulatory strategy and quality risk management guidance (Q8, 9)for regulatory approvals (Phase 1 to Post Approval) for worldwide markets - US, Europe, Canada, Japan, S. America and ROW.