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Dossier Services




service

Services we provide

first of all Pharmaactddossiers writes dossier that meet all regulatory requirements and is in accordance with all legal demands. PharmaActdDossiers Service is a leading international services organization that helps customers to because many challenges come within the rapidly evolving global pharmaceutical market.

Service

Therefore We are offering dossier as per European CTD / ASEAN CTD / non-CTD (country specific guideline). Pharmaactddossiers offers supportive services of medical writing to pharmaceutical companies as follows:

  • Pharmaactddossiers writing Dossier in required format for registering the products in world wide markets like EU, USA and ROW countries in CTD format and as per country specific guidelines for any dosage form.
  • Drug Master File (DMF) compilation for open and closed part,
  • Provide support in conducting Structural elucidation of substances, impurity profiling and related validations and stability studies.
  • Preclinical and clinical overviews writing through literature search / published studies / articles from journals from different sources.
  • Expert reports on Quality ,  Pre-clinical and Clinical
  • Prepare summary of product characteristic (SmPC), Pack Insert, Product rationale.
  • Periodic Safety Update Report (PSUR) preparation.
  • Mutual Recognition Procedure documents preparation.
  • Provide support in responding to queries from Regulatory Agencies, timely submission of all types of variations, including change of ownership, change of manufacturing sites and new indications.
  • Review of dossiers prepared by Indian companies for registering products in EU by our European counterpart.
  • Total development of product from lab scale to pilot plant scale to actual production scale for Drug Substance and Drug product.
  • Provide analytical support in analytical method development / validation, Routine analyses of products by HPLC/GC/MS etc., Product characterization and Impurity profiling at our associate company STABICON.
  • Complete stability programme management service is provided as per ICH guidelines / special requirements in a cGMP and GLP compliant environment at our associated company STABICON.
  • Business Development and Business consultancy is provided on various aspects related to Product Development and Contract Manufacturing both for Domestic and Export markets.
  • Monitoring and liaisoning with the CRO’s for PV or PhV (Pharmacovigilance Study Report) & BA/BE ( Bioavailability /Bioequivalence) Studies Reports

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