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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