DMF / Dossier

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Dossier Development

  • costarica is engaged in Dossier Development for highly regulated markets like US, EU and ROW markets.
  • We are also involved in Preparation and Submission of DMF and CoS, Submission for EU as per EDQM, UK as per MHRA, Australia as per TGA, South Africa as per MCC, Brazil as per ANVISA and CIS Registration besides compilation of dossiers in CTD Format,
International Regulatory Affairs at COSTARICA PHARMACEUTICALS:

Our Service includes Developing Regulatory Strategies, Comprehensive Documentation, Submission and Archiving of Documents. Regulatory Department also oversees the compliance program, ensuring that all practices conform to the constantly changing regulatory requirements.

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  • Preparation and Submission of Drug Master File (DMF)
  • Preparation of Site Master File (SMF)
  • Generation of Dossier as per European Union and US Guidelines
  • Pre-Inspection Audit
  • Assistance for getting Certificate of Suitability (CoS)
  • Reply to Queries
  • Writing Expert Reports
  • Drafting and Editing all sections of DMF
  • Documentation of the following
  • Drug Substance Characterization
  • Manufacturing and In-process Controls
  • Stability Study
  • Product Development Reports (PDR)
  • Process Validation Protocol and Reports
  • Method Validation Protocol and Reports
  • Technology Transfer
  • Chemistry, Manufacture and Control (CMC) information
  • Abbreviated New Drug Application (ANDA) - US
  • API European Union Registration - EU
  • Medicines & Healthcare Products Regulatory Agency (MHRA) - UK
  • Therapeutic Goods Administration (TGA) - Australia
  • Medicines Control Council (MCC) - South Africa
  • Commonwealth of Independent States (CIS) Registration
  • Registration in all other Regions across the globe

Medical writing is an integral part of clinical research. Our Medical writing services include regulatory and scientific writing.

Regulatory Writing:
  • Clinical Study Protocols
  • Informed Consent Documents & Subject Information Sheets
  • Clinical Study Reports
  • Public Disclosure Synopsis & Lay Summaries
  • Investigator Brochures
  • Clinical and nonclinical sections of Common Technical Document
  • Safety reporting documents likes Periodic Safety Update Reports, Development Safety Update Reports
  • Clinical Evaluation Reports for Medical devices.
Scientific Writing:
  • Manuscripts
  • Abstracts
  • CliniPoster Presentations
  • Literature Reviews

Other Service