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Broadly, the areas in which Pharmaffiliates offer services are:
- Analysis of pharmaceutical drug substances, drug products and raw materials
- Custom Synthesis
- Impurity synthesis
- Impurity profiling
- Structure elucidation
- Polymorphism studies
- Analytical Method Development
- Method Validation & Transfer
- Stability studies & Evaluation
- Regulatory affairs
- Quality Management
- Dossier preparation
- Submission and Approvals from the Regulatory Authorities worldwide
- GMP Training
- Auditing
- Marketing Support to SMEs.
Analysis of pharmaceutical drug substances, drug products and raw materials
Testing of APIs, Drug product, raw materials and excepients is a necessary requirement in providing quality assurance to clients and ensuring the safety of end users.
Pharmaffiliates operate on a global basis and provide different tests using a diverse range of analytical techniques. Pharmaffiliates analytical testing laboratory network offers comprehensive analytical testing capabilities and techniques. Analytical laboratory techniques include:
- Chemical Analysis
- Identification (by HPLC,UV,IR,TLC etc)
- Chromatographic Purity (by HPLC,GC,TLC)
- Related substances (by HPLC,GC,TLC)
- Vitamin by HPL
- Content uniformity (by HPLC,UV,Titration)
- Residual solvent/OVI by GC-head space
- Dissolution profile
- Dissolution test
- Assay % w/w
- Limit test
- Friability test
- Disintegration time
- Microbial analysis
- 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
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