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Regulatory Support 

Our team has successfully partnered with industries to perform mainly, but not limited to

Post-Marketing / Pharmacovigilance

  • Epidemiological and clinical reviews, 

  • Evidence generation utilizing RWE (adverse events and Market data analysis),

  • Signal detection and evaluation,

  • Developing PBRER, PSUR, PADER, RMP, RMM

Labeling and Product Information

  • SmPC – EU,

  • PIL

  • MedGuide,

  • PI

Clinical Development

  • ​Clinical Trial Protocols,

  • ICFs, CSRs, CRFs, DSUR, IND

  • Safety Reports, GCP Compliance Reports

  • Regulatory Submissions; IND & CTA Application, CTD [FDA, EMA, MHRA]

Preclinical / Nonclinical Development 

  • IB, GLP-compliant

  • Acute, sub-chronic, chronic Toxicology (Genotoxicity, Carcinogenicity, and Reproductive toxicity)

  • Safety pharmacology,

  • Pharmacokinetics & ADME Reports,

  • Summary of Nonclinical Data

Our Team's PUBLICATIONS

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