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Pharmaffiliates- An Official Reference Standard Partner

European Pharmacopoeia (EP), under the scientific and administrative support of European Directorate for the Quality of Medicines & Healthcare (EDQM), provides common quality standards to be followed by the pharmaceutical industries in Europe. These standards are used to maintain the quality of the drugs and other substances manufactured by the pharmaceutical industries in Europe used for both human and veterinary purpose.

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Pharmaffiliates- An Official Reference Standard Partner

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  1. Pharmaffiliates- An Official Reference Standard Partner European Pharmacopoeia (EP), under the scientific and administrative support of European Directorate for the Quality of Medicines & Healthcare (EDQM), provides common quality standards to be followed by the pharmaceutical industries in Europe. These standards are used to maintain the quality of the drugs and other substances manufactured by the pharmaceutical industries in Europe used for both human and veterinary purpose. EDQM provides Reference substances in the form of chemical reference substances (CRS), herbal reference standards (HRS) and biological reference preparations (BRP) as well as reference spectra for the tests and assays to be carried out in accordance with the official methods provided in the monographs of European Pharmacopoeia. EP reference substances are highly purified substances and these are used as part of the relevant official monograph. These reference substances provide the means to verify the compliance of a material with the requirements of the monograph. Pharmaffiliates Analytics and Synthetics Pvt. Ltd. is a leading supplier of EP reference substances in India and globally at a competitive price. All the EP reference substance are available in sealed vials and in desirable pack sizes. To cater more requirements of Pharmaceutical laboratory analysis, Pharmaffiliates also provides Pharmacopoeial Reference Standards of United States Pharmacopoeia (USP), British Pharmacopoeia(BP), Japanese Pharmacopoeia(JP) and Indian Pharmacopoeia(IP) at a very competitive price. Pharmaffiliates as an integrated Contract Research Organization provides a full range of services like •Impurity synthesis •Custom Synthesis •Impurity profiling •Isotope-labeled Materials •Polymorphism studies •Analytical Method Development •Method Validation & Transfer •Stability studies & Evaluation •Regulatory affairs •Quality Management •Dossier preparation •Trainings and audits 1

  2. Pharmaffiliates- An Official Reference Standard Partner Pharmaffiliates has subject matter experts, who are engaged in the synthesis of impurities and metabolites of APIs and FPPs which include antibiotics, steroids, chiral, achiral drugs, and isotope-labeled compounds. Pharmaffiliates Analytics and Synthetics is a leading name in the global market offering services to Pharmaceutical industry, API manufacturers, Bulk drug suppliers, clinical CROs and other allied industries. Under the guidance of our founder director, Dr. A.K Sabharwal who is having over 35 years of industrial experience in Pharmaceutical Research, Quality Assurance and Regulatory Affairs with various global pharmaceutical giants, Pharmaffiliates team has been able to achieve major milestones like ISO 9001:2005, ISO 17025, ISO Guide 34 and it is audited and accepted by USFDA as well. 2

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