Topic Name : QPPV

Website URL : http://www.acplgroupindia.co.in/

Website Title : Accredited Consultants Pvt Ltd - Healthcare Regulatory Services

Website Description : ACPL is one of the leading regulatory consultant service providers based in Delhi (India), for drugs, medical devices, food and cosmetics. We provide the complete range of services covering regulatory affairs, pharmacovigilance, clinical trial and medical writing.

Keywords Used : ACPL - Healthcare Regulatory Services ,New Drug Registration in India,New Drug Registration,central drugs registration, central drugs registration in india, new drug application in india, new drug application, drug & medical registration in india, drug & medical registration, new drug & medical registration in india, drug registration in india, cdsco registration, diagnostic registration in india, diagnostic registration, medical registration in india, medical device registration in india, cosmetic registration in india, cosmetic registration, regulatory consultants india, drug consultants in india,drug consultants, new drug consultants, drug licences in india,drug licences,drug licences registration, ICSRs, Case processing 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 Medical Writing, Clinical Writing Investigator Brochures Clinical Study Protocols Informed Consent Documents Patient Diary Cards Case Report Forms Clinical Study Reports Clinical Summaries/Product Feasibility Reports for Medical Devices Regulatory Writing Common Technical Documents Clinical and non-clinical overviews Summary of product characteristics Pack Insert and Labels Clinical expert statements Briefing documents NDAs/ANDA/IND Company Core Safety Information (CCSI), Company Core Data Sheet (CCDS) Summary of Product Characteristics (SmPC) Literature and Brochure for medical devices Drug Registration Consulting in India Drug Registration Consulting India Drug Registration Consultant India CDSCO Medical Device Guidelines Food License in India Drug Registration in India CDSCO medical device regulations CDSCO consultants CDSCO Medical Device Guidelines CDSCO Medical Device Cosmetic Registration Cosmetic Registration India Cosmetic Registration in India Cosmetic Registration drug license Cosmetic Registration drug license India CDSCO Medical Device CDSCO Medical Device India drug import license services in India drug import license of India drug import license registration in India Drug regulatory services in India Cosmetic Registration drug import Cosmetic Registration drug import India DCGI-Indian regulatory authority CDSCO India Drug regulations Drug Registration/ license Consultant India Medical Device Registration/ license Consultant India Cosmetic Registration/ license Consultant India Drug regulatory services India Drug and cosmetic act Drug regulations Food License in India Drug/Device import in India Drug Registration Delhi Dossier Compilation (eCTD, ACTD, NeeS, National Filing) for Europe/US/Australia IND, NDA and ANDA Pharmacovigilance services in EU, USA, India, Russia CIS countries PVG modules, European Medical Agency Adverse event reporting, ICSRs E2B reporting Pharmacovigilance guidelines USFDA Pharmacovigilance consultant Clinical trial reports

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