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Adveesan Pharma Consulting is a Global Regulatory, Pharmacovigilance and Clinical Development Consultancy based at Amsterdam; Netherlands and Mumbai; India.

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About us

Adveesan has expertise in area of Global Regulatory strategies, Documentations, Submissions and Life Cycle Management of Drugs, Vaccines and Device

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Our Experts

Adveesan Consulting we have built a culture with great emphasis on Collaboration, Responsiveness and Excellence to customers.

Our Experts

Our SERVICES

Regulatory Affairs

Regulatory Affairs

Regulatory at Adveesan Consulting offers a broad range of services including:

Scientific Advice

  • EMA: Scientific Advice & ITF Briefing Meeting, Pre-Submission Meeting
  • Member State Scientific Advice
  • FDA: Pre-IND, EOP2, Pre-BLA
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Medical Writing

Medical Writing

Medical Writing at Adveesan Consulting offers a broad range of services  includeing:

Clinical Trial Application Documents-

  • Clinical Protocol
  • Informed Consent Form
  • Investigator Brochure
  • Investigational Medicinal Product Dossier (IMPD)
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Pharmacovigilance

Pharmacovigilance

Pharmacovigilance at Adveesan Consulting offers a broad range of services including:

  • Periodic Benefit-Risk Evaluation Report (PBRER)
  • Periodic Safety Update Report (PSUR)
  • Periodic Adverse Drug Experiences Report (PADER)
  • Risk Management Plan (RMP)
  • Annual Safety reports,
  • Company Core Data Sheets (CCDS) updates,
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GxP

GxP

Good Clinical Practice (GCP) and Good Vigilance Practice (GVP) Services

  • Audits and inspections
  • Gap Analysis- processes and systems
  • Trainings and Work shops
  • GxP Awareness Programme
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Our

Experienced team

Parminder Kaur

Dr.Ghanashyam Nagoji Rao

Chief Clinical Development Expert And Co-Founder

Dr.Ghanashyam Nagoji Rao is Medical Graduate ( Seth GS Medical College and KEM Hospital, Mumbai) with 15 years of experience in Clinical-Regulatory Strategy (USFDA & EMA, EU Nationals and UK ), Clinical Development, Medical Review...

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Dr.Ghanashyam Nagoji Rao

Dr.Ghanashyam Nagoji Rao

Chief Clinical Development Expert and Co-Founder

Dr.Ghanashyam Nagoji Rao is Medical Graduate ( Seth GS Medical College and KEM Hospital, Mumbai) with 15 years of experience in Clinical-Regulatory Strategy (USFDA & EMA, EU Nationals and UK ), Clinical Development, Medical Review/Medical Monitoring, Regulatory Medical Writing, Bio-Equivalence & Pharmacokinetics studies with training on Medical Writing/ Medical ...

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