DRUGCONSULTANTS 5aa63fc38783010e4427572b False 564 6
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FSSAI COMPLIANCE There are several guidelines and regulations under FSSAI which keep updating. It becomes difficult for manufacturers and importers in India to keep themselves updated on the same. We provide end to end support to the manufacturers and importers in India for the FSSAI compliance. Being an FSSAI license consultant, Our services include but are not limited to labeling analysis as per the FSSAI Packaging and Labelling regulations, 2011, ingredient and additive analysis, RDA analysis, formulation designing and review for product compliance as per acceptability in FSSAI.
Pharmacovigilance consultant in Delhi DCGI, CDSCO, Drug, Medical Device, cosmetic Registration/ license Consultant in India Drug regulatory services India Drug and cosmetic act Drug regulations India Drug Registration Delhi CDSCO Drug Registration consultant Drug/device/cosmetic import License services in India Food License in India CDSCO India Drug import in India Dossier Compilation for Emerging Markets/EU/US/Australia Types – eCTD, ACTD, NeeS, National Filing Preparation and filing of documents IND, NDA and ANDA Dossier conversions to CTD/ACTD for Drugs & to CSDT for Medical Devices CPP, DMF Reviews FDA/DCGI liaison meeting PIL User Testing API filing with EDQM for obtaining CEP Product label maintenance Import Licenses Registration PV Pharmacovigilance consultant Pharmacovigilance services in EU, USA, India, Russia CIS countries PVG modules, European Medical Agency Pharmacovigilance guidelines USFDA Adverse event reporting, ICSRs E2B reporting Clinical trial reports Medical device related reports Literature reports Aggregate & Periodic Report Writing PSURs, PBRERs, PADERs, DSURs, Bridge reports, Annual safety reports etc. Signal detection & Management Risk Management Plans (RMPs), REMS PSMF, QPPV (Qualified Person for Pharmacovigilance) PV audit and inspection Clinical Trial Monitoring Clinical Project management Clinical Trial Set-up Regulatory Affairs for Clinical Trials Patient Safety/Pharmacovigilance in Clinical Trials Clinical Data Management Clinical Biostatistics Services
Section 510 of the Federal Food, Drug, and Cosmetic Act (FD& C Act) requires firms that manufacture, prepare, propagate, compound, or process drugs in the U.S. or that are offered for import into the U.S. to register with the FDA. These domestic and foreign firms must at the time of registration, list all drugs manufactured, prepared, propagated, compounded, or processed for commercial distribution in the U.S. Additionally, foreign establishments must identify a U.S. agent and importers at the time of registration. DCGI, CDSCO, Drug, Medical Device, cosmetic Registration/ license Consultant in India Drug Regulatory Services India Drug and cosmetic Act Drug Regulations India Drug Registration Delhi
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