I-Regulatory

Experienced team providing regulatory support for drug product approvals. Services include strategy, project management, meeting coordination, and labeling.

I-Quality

Experienced team in regulatory compliance & quality. Experienced in GMP audits, quality system evaluation, investigations, vendor qualification, training, compliance monitoring etc.

I-CRL

Chemical Research Lab Services: Custom synthesis of APIs, intermediates, impurities. Reverse-engineering, scale-up, and purification capabilities.

I-Technical Services

Clinical & non-clinical data analysis, summaries. Risk assessment for impurities. Health-based risk assessment. Pharmacopeia updates. Elemental & nitrosamine assessments.

I-Training

Formulation & development support, tech transfer, CMC documentation. Regulatory, quality, analytical, packaging SMEs. Training in GMP/GLP/GDP, regulatory affairs.