Pharmaffiliates Analytics & Synthetics
Pharmaffiliates Analytics & Synthetics (P) Ltd, is an integrated CRO (Contract Research Organization) established in year 2001. Presently we are US-FDA Audited & Accepted Facility and bagged with ISO 17034, ISO 17025 & ISO 9001 Certification. We are specialized in research via synthesis of complex and difficult to make compounds (Impurities & Metabolites), innovative organic molecules to support and accelerate the drug discovery research of pharma and biotech companies. We adapt unique synthetic approaches and execute in robust ways for making complex and unknown impurities with their characterization data. Thus we make the drug discovery process more efficient, cost-effective while maintaining the highest standards of quality. With the collective efforts of our team of 130 scientists so, far, we have performed more than 300 method validations & many of these validation reports submitted to EU & US & sought approvals. Work is carried in line with the ICH and the cGMP guidance.
Our experience, combined with state-of- the-art laboratories and manufacturing facilities lets us become an ideal partner for the pharmaceutical and drug discovery industry , we undertake projects for Process Research, Scale up , Custom Synthesis, CRAMS, Impurity synthesis, Isotope labeled compounds (Deuterium Compounds), Chiral Compounds, Phytochemicals, Glucuronides, Reference Standards, Polymorphism studies, Analytical Method Development & Validation, Stability studies & Evaluation are of our core group activities.
So far we have successfully established a library of more than 30000 compounds with their complete characterization data.
Our Products & Services :
1. CUSTOM SYNTHESIS
A. Impurities & Metabolites
B. Stable Isotopes - Deuterium & Labelled Compounds
C. Typical compounds - Dimers, trimers, etc.
D. Pesticides, Phytochemicals, Petrochemicals
2. ANALYTICAL SERVICES
A. Identification of Unknown Impurities
B. Impurity Profiling
C. Method Development & Method Validation
D. Stability Studies
E. Transfering Technologies of APIs
F. Forced Degradation Studies
3. REGULATORY SERVICES
A. DMF Filing
B. Dossier Preparation
C. Process Development
D. New Molecule Development
E. Third Party Audits
FTE, Fixed Bid, Milestone based options
Each and every Standard supplied with detailed COA including the complete structure elucidation and interpretation supported data i.e IR, NMR, MASS & HPLC Chromatogram. Also any additional data like 13C-NMR, C-HNS, Q-NMR & TGA can be provided on special request. Majority of our Impurities are above 95% purity. Impurities and standards which are not available in our catalogue can be Custom Synthesized as per your requirement.
|Sales markets||Western Europe; Eastern Europe; Middle East; Asia; Australia; North America; Africa; Central/South America|
|Affiliated categories:||Analytical Chemistry |Analytical Development |Analytical Methods More|
CPhI & PMEC India 201926 - 28 November 2019 India Expo Centre, Greater Noida, Delhi NCR We were at stand 4.G15 See our Exhibitor Profile See full Exhibitor List
CPhI Worldwide 20195-7 November 2019 Frankfurt, Germany We were at stand 80L43 See our Exhibitor Profile See full Exhibitor List
Our Top products
Computer Software for Commercial Producers and R&D laboratories
Laboratory information management system (LIMS)Electronic Laboratory Notebooks (ELN) Enterprises Resource Planning (ERP) Customised Application Development (Online/Offline) For Sales, Purchase, Stores, R&D, Production,QA/QC, DispatchMore info
Pharmaffiliates is Supplying all the Pharmacopoeial Reference Standards (i.e. USP, EP, BP, IP, JP).Apart from this we offers Pesticide Standards, Phyto-chemical Standards, Food & Environmental Standards, etc.
For more details please send your enquiry on [email protected]
Pharmaffiliates Analytics & Synthetics (P) Ltd, is an integrated CRO (Contract Reserach Organisition) established in year 2005. Presently our group is consist of more than 65 Scientists with 3 R&D Centres offering its expertise in Custom Synthesis, Impurity synthesis, Isotoped lebelled compounds ...More info
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