As an integral part of product development FTUG provides analytical method development services. Additionally, FTUG also provide standalone method development, method validation, routine testing and stability testing services in compliance with FDA/EMA and ICH guidelines.FTUG has experience in providing analytical services for regulatory submissions. We provide timely support for regulatory submission and responding regulatory deficiencies.
Method Development and Validation:
FTUG has state of art testing facility in compliance 21 CFR 210 and 211 and ICH cGMP requirements. Our lab is equipped with all ultra-modern analytical equipment.
We provide method development and validation services for all kind of testing methods along with method transfer to testing facilities. FTUG provides all the analytical method validation documents in line with ICH 2 guidance document. FTUG is equipped with sufficient instruments and manpower to provide you quality services within the agreed timelines.
Analytical Testing and Stability studies:
FTUG provides routine analytical testing and stability study services for pharmaceutical companies. We have well equipped testing lab with automated stability chambers.
FTUP is testing facility is built in compliance with 21 CFR 210 and 211 and ICH cGMP requirements.
The method development and validation services include providing test methods and validation reports drafted to in-house requirements or client specifications.
- Analytical Methods Development
- Method Feasibility/Pre Validation Studies
- Analytical Method Validation
- Analytical Method Transfer
Services include :
- Impurity Profiling
- Preformulation Studies
- Drug substance evaluation and comparability protocol
Stability Testing and Retain Sample Services :
- In-House Stability Storage Services according to ICH Guidelines
- Specialized Storage Services according to client specified conditions
- Stability Testing Services
- Stability Protocol and Report Preparation
- Stability Data Analysis and Specification Proposal
- Retain Sample Storage Services
- Annual Inspection of Retains
Special Testing :
- Process Validation Testing
- Cleaning Validation Methods Development, Validation and Testing
Products for Testing :
- Active Pharmaceutical Ingredient.
- Impurities/degradation products/related compounds
- OVIs/Residual Solvents
- In-process and Finished dosage form
- Solid Oral Dosage Form- Tablets, Capsules, Powder, Pellets etc.
- Liquid Dosage form
- Analytical Instrumentation
- Infrastructure meeting global development standards.
- Segregated lab areas for different testing processes.
- Lab area designed to avoid cross contaminations.
- State-of-the art facility with 21-CFR Part 11 compliance.
- All equipments are networked for integrity of operations.
We provide testing services using state of the art analytical instrumentation. Our chemists have expertise and are well versed in the use of a wide range of instrumentation including:
- HPLC (UV, PDA, RI, Fluorescence, Osmometer & ECD/PAD Detectors)
- GC & Headspace Analyzer (FID, TCD)
- Karl Fischer Titrator (Volumetric & Coulometric)
- pH meter
- Analytical and Micro Balance
- Dissolution System with Dissolution Sampler
- Spectrophotometers (UV, IR)
- Tap Densitometer
- Rotary Evaporator
- Stability Chambers
- Conductivity Meter
For more information on your all testing needs please contact us.