Please ENTER to search

Menu

Stage Gates for API Development Process

Stage Gate Adopted for API Development

01

Feasibility

02

Optimization & Standardization

03

Process Engineering & Safety Studies

04

Analytical Method Development and Validation

05

Crystallization & Particle Engineering

06

Vendor Qualification & Documentation

07

Genotoxic impurities & Nitroso-amine impurities risk assessment & Establishment

08

Kilo Lab & Scale up Studies

09

Exhibit Campaign as per the ICH

10

Regulatory stability studies for all zones

11

DMF filling & Packing configuration

12

Backward integration of KSMs to meet the regulatory requirements & cost

13

Development & Validation Report

Footer Form Banner

Ready to discuss your needs with us?

Request you to provide all details mentioned in the form along with your business requirement. It will help us route your query to the appropriate person.

Please enter a valid name (only alphabets and spaces allowed).
Please enter your organization name.
Please enter a valid work email address.
Please enter a valid phone number.
Please select your country.
Please enter your message.
You must agree to the privacy policy.