We work with pharmaceutical and biotech companies on CDSCO submissions, clinical trials under the New Drugs and Clinical Trials Rules 2019, and the post-approval obligations that follow. Indian regulatory practice, handled by people who do it regularly.
Working with Indian and international pharmaceutical companies, CROs and manufacturers
Most Indian delays are not scientific. They are procedural, and they are avoidable.
New drug and import applications, dossier compilation, SUGAM filing, and responding to Subject Expert Committee queries without restarting the clock.
Read moreTrial permission under the NDCT Rules 2019, Ethics Committee and CTRI sequencing, site readiness and the documentation inspectors ask for.
Read moreSafety reporting into PvPI, periodic safety update reports, and the systems that make those obligations sustainable rather than a scramble.
Read moreCompanies arriving from an FDA or EMA background often assume the Indian dossier is the global one with a different cover letter. It is not. The evidence expectations differ, local clinical data may be required, the Ethics Committee and CTRI steps have their own sequence, and the Subject Expert Committee route has no real equivalent elsewhere.
We also work on FDA and global submissions through techworkslab.com, so when a programme runs in both directions the two dossiers stay consistent with each other.
Tell us the molecule, the indication and where you are in the process. We will tell you what the realistic path and timeline look like.
Talk to our regulatory team