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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
Drugs & Cosmetics Sales License ( Ozg License Consultant for Retail Chemist / Cosmetics Shop in Delhi - NCR ) Ozg Registration, Approval & Licensing, More information contacts us. Regulatory Affairs Service in Indi, Regulatory Affairs Service in Delhi, Regulatory Affairs Service in Noida, Regulatory Affairs Service in Ghaziabad
Food & Drugs Regulatory Service specializes in providing customers with expert regulatory solutions for the development of new drugs Medical device, Vaccines, Cosmetics and Food based Products in India. More information contact us. Drugs regulatory service in Delhi Drugs regulatory service in Gurgaon, Drugs regulatory service in Sonipat Drugs regulatory service
Food & Drugs Regulatory Service specializes in providing customers with expert regulatory solutions for the development of new drugs Medical device, Vaccines, Cosmetics and Food based Products in India. More information contact us. Drugs regulatory service in Mayur Vihar Delhi Drugs regulatory service in East Delhi, Drugs regulatory service in West Delhi Drugs regulatory service in South Delhi
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