Regulatory Affairs and Medical Writing

Regulatory Affairs

  • Prepare regulatory dossiers as per regulatory guidelines
  • Submit regulatory dossier, subsequent query resolution, and follow up
  • Cardiac Safety Studies / Thorough QT/QTc Studies
  • Obtain import/export licenses for Investigational products and Clinical Trial Samples
  • Liaison and follow up with regulatory authorities
  • Trial related update submissions, approvals to ECs and applicable regulatory bodies
  • Drug and Device Regulatory Consultation
  • CE Marking for Medical Devices
  • Compile and submit Marketing Authorisation Applications using the most appropriate regulatory submission pathway
  • Prepare for Scientific Advice meetings
  • Define Regulatory strategy and support
  • New Drug Approvals
  • Global Clinical Trials
  • Medical Device Registrations
  • IND dossier preparation and meetings
  • Pre-IND dossier preparation and meetings

Medical Writing

  • Concept Sheet preparation for generic ANDA submissions
  • Clinical study protocol writing for phase II to IV studies
  • Write Clinical Study Protocol for Phase I and Patient-based PK studies
  • Patient informed consent forms, documents and brochures
  • Write ICH E3 and CDISC compliant Clinical Study Report
  • Protocol Development for proof of concept and early phase clinical trials
  • Clinical and non-clinical sections of the Common Technical Document (CTD) including summaries and overviews for EU and US Regulatory Authorities
  • Investigator Brochures
  • Standard Operating Procedures (SOPs) covering all aspects of drug development including the design, conduct, reporting of clinical trials and outsourcing Sponsor responsibilities to a Clinical Research Organization (CRO)

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