Services
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Technical
QbD based product development assistance for Finished Dosage Forms (Oral Solid Dosage-Tablets & Capsules) and APIs (Chemistry based)
Process improvement and Optimization assistance for Chemistry based APIs
Lab to GMP area process scale-up support for Chemistry based APIs with emphasis on mapping changes to Critical Process Parameters (CPP)
Kilo scale range custom synthesis with lot size between 100g to 5000g in a GMP environment
Technology Transfer support for Finished Dosage Forms (Oral Solid Dosage-Tablets & Capsules) and APIs (Chemistry based)
Onsite support for handling trouble shooting in manufacturing steps of Finished Dosage Forms and Chemistry based APIs
Expertise in Validation/ Qualification of Area, Process and Cleaning
GMP Allied
Compilation, review and verification of Regulatory filing for ANDA, Drug Master File type II and type III filings
GAP Assessment for preparedness to Regulatory agency inspections
Product & activity risk assessment support
In-licensing & Out-licensing manufacturing assistance for Finished Dosage Forms and Chemistry based APIs
CAPA and Remediation Action Plan (RAP) development against non-compliances noted during Regulatory agency inspections
Third party quality audits for Medical devices, Excipients, Packaging materials, Drug Substance, Drug product manufacturing sites
Reach us at
Dr.Narasimha Murthy
+91 740619672
murthy@inobelpharma.com
Dr. Harsha Jinadatharya
+91 9945028236, 9886288897
harsha@inobelpharma.com