SG CONSULTING Privatpraxis Integrated Pharmacovigilance & Research Laboratory
SG CONSULTINGPrivatpraxis    Integrated Pharmacovigilance & Research Laboratory 

ISO 9001:2015 Reg. Nr. 731005745

Mitglied der PBV 

Privatärztlicher Bundesverband e.V.

„Hope, vision, and well-being for each patient through integrated clinical practice, education, and research“

SAFETY REPORT WRITING

 

SG Consulting has extensive experience in thorough and accurate reports that meet regulatory requirements [§ Good Pharmacovigilance Practice (GVP) - Modules II, V, VI, VII and IX]:

 

  • Periodic Safety Update Reports (PSURs) and Periodic Benefit Risk Evaluation Reports (PBRER)

  • Development Safety Update Reports (DSURs)

  • Risk Management Plans (RMPs)

  • Benefit Risk Assessments

  • Quality control and consistency check of all safety documents

  • Pharmacovigilance System Master File (PSMF) updates

  • Safety Data Exchange Agreements (SDEAs)

  • Safety sections of the common technical document (CTD) and investigator brochure (IB)

  • Addendum to Clinical Overview (ACOs)

  • Clinical Expert Statement or Scientific Expert Statements to be used as parts of Addendum to Clinical Overview or similar submission documents;

  • Risk or signal analysis documents / Signal Detection Reports / Signal Evaluation Reports

  • Cumulative or Aggregate Safety Reports in response to authorities’ requests

  • Responses to Competent Authorities (CA)

  • Systematic or Customized Reviews of Pre-clinical / Clinical Safety Data

  • Systematic Reviews of Evidence (based on Cochrane tools and standards)

  • Cochrane Clinical Answers (CCAs) – Hematology & Oncology

  • Product Quality Reports (PQR)

  • Investigational Medicinal Product Dossiers (IMPD) and update reports

  • Patient Information Leaflets (PIL)

  • Clinical Study Protocols (SP)

  • Clinical Study Reports (CSR)

  • Interim Safety Analysis Reports

  • Biometric analysis reports for clinical trials

  • Meta-analyses (with and without appropriate software tools)

  • Gap-analysis reports

  • Competitor analysis reports

  • Consultancy reports

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