Services

Drug Safety & Pharmacovigilance

Home Drug Safety & Pharmacovigilance

Our pharmacovigilance team support post-marketing safety surveillance and clinical trial and across the globe. As patient safety as the critical component, our quality focus aligns us to collaborate with Pharma and Biotech companies to provide both standalone and integrated services throughout the lifecycle of a product.

Capabilities-in a Glance

E2B R2 and R3 Compliant Safety Database

Literature Surveillance & ICSRs Processing and Submission

Medical Review

Safety Reporting, Aggregate writing & Signal Reports

RMP & REMS Compilation

RPP, QPPV & Dy QPPV Services

MICC, Migration, Gateway Establishment, SDEA's

Services Offered

  • PV Database : Setting up and hosting of database & management
  • Migration of cases
  • Legacy Data Migration
  • SDEA (Co-licensing, Third party Manufacturer/Distributor, Piggy back ..etc)
  • PSMF
  • Support with third parties and Channel Partners
  • PV consulting involving SOP development, quality systems and strategic consulting
  • System Audits
  • End to end ICSR case processing including electronic transmission
  • Dedicated clinical trials team with experience processing cases from early dose determination studies to advance phase 3 clinical trials
  • Medical review case assessment
  • Integrated PV and Medical information (MI) response centers
  • Global literature monitoring
  • Aggregate report preparation and compilation (PSURs, PBRERs, PADERs, CASRs, DSURs etc)
  • End-to-end signal management activities
  • Routine risk monitoring activities
  • Preparation and review of RMP
  • MAH oversight and support including training, SME review and gap analysis of Risk Management Measures

Experience & Expertise

Our pharmacovigilance team brings extensive experience and expertise to managing end-to-end operations, ensuring seamless delivery of pharmacovigilance services. Renowned for their reliability, agility, and adaptability, they navigate challenges with ease, safeguarding patient safety and maintaining regulatory compliance at every step of the process.

18+

Experience

800+

ANDAs

450+

MAs

30000+

ISCRs

8000+

PADERS

1000+

PBRERs/PSURs

300+

ACOs

200+

RMPs

1000+

Signal Reports

300+

SDEAs

Regulatory Audit Experience

Advantages

Experience in managing end-to-end PV services and understanding the challenges faced by small, medium & Big pharma companies

Experienced team of SME and Physicians with extensive therapeutic area expertise and strong medical & safety service

Robust planning and processes in place to ensure smooth project transitions including Data migration

Strong expertise in handling ever-changing regulatory requirements

Wide-ranging experience with multiple regulatory regions

Audit ready quality processes, Anytime Inspection Readiness

Highly adaptable with proven collaboration across the functional areas

Risk mitigation strategies with strong business continuity plan

We are here to help you meet the strict regulatory requirements in your next project. Connect with our GM Pharmacovigilance

Sarva Raidu - GM Pharmacovigilance
+91 40 69089999
bd@advityresearch.com