Analytics
The validation work will be primarily taken for the Regulated markets and all the studies are performed in accordance with 21 CFR part 11. This lab meets the compliance expectation of the European, US and other Regulatory authorities.
| We welcome clients and their customers to audit us and verify our compliance with current Good Manufacturing Practices. This CRO meets the compliance expectation of the European, US and other Regulatory authorities. |
Method Development, Validation & its Transfer
Pharmaffiliates has extensive experience on Analytical Method Development, Method validation and Methods transfer. Numerous analytical methods has been developed, validated and transferred successfully. Care is taken in developing the methods which facilitate the Structure elucidation during LC-MS studies.
In case of help Pharmaffiliates technical team can be deputed in your premises for providing timely help and achieve successful Method transfer. We emphasize the concept of Method familiarization which can be achieved by telephonic discussions or video conferencing.
The validation work will be primarily taken for the Regulated markets and all the studies are performed in accordance with ICH requirements.
Stability Storage & Testing
We provide stability testing on Drug Products specially during development and Post surveillance study.
Our stability operations have extensive storage capacity for all ICH conditions as well as custom storage conditions. All of our chambers are continuously monitored through a computer database system and are on full generator back-up.
Core testing and analysis expertise covers: R&D preliminary studies, finished product, API's, high throughput QC stability & release testing, comparator studies and additional capabilities for photo stability studies.
All stability studies are performed in accordance with the ICH Q1A-Q1F. For these Stability Indicating Methods are developed and made use of while performing Stability studies for the APIs and Drug Products.
All stability ovens, Walk in Chambers and Analytical instruments are fully qualified. Majority of the analytical instruments are 21CFR part 11 compliant.
- Compliance with Global Quality Standards.
- Commitment to Quality and Timely deliverance.
- Qualified and Competitive team.
- Quality at a Reasonable cost.
- Ready to face audits by worldwide Regulatory authorities.
- First Indian company to perform audits for European customers in accordance with EMEA requirements.
- Our 2500 Impurities synthesized
- Our 300 Methods Developed & validated
- State of the Art Facilities
- Working for European and US customers