Chemistry, Manufacturing & Controls – SRAMAN Life Sciences

Chemistry, Manufacturing & Controls

Chemistry, Manufacturing & Controls

01

Helping clients develop scalable, regulator-ready manufacturing processes for small molecules and biologics.

02

Selecting and auditing CDMOs in India with the right capabilities (GMP, sterile, biologics, etc.).

03

Overseeing process validation, stability studies, and comparability exercises before clinical material production.

04

Preparing CMC sections of IND/IMPD dossiers, ensuring that the manufacturing story is consistent, reproducible, and audit-ready.

Typical Deliverables

1 Study plan and protocol synopses aligned to ICH M3 and OECD guidelines

2 Tox package roadmap covering acute, sub-chronic, chronic, and repro-tox phases

3 Safety pharmacology plan (core battery and follow-up studies)

4 Pathology and peer-review plan (histopathology readiness checklist)

5 Tox data review reports and deviation/CAPA summaries

6 Audit-ready study folder with raw-to-report traceability documentation

Connect with Experts

Our Expertise