DSPV Consultancy

DSPV Consultancy

Strategic Pharmacovigilance & QPPV Partner

DSPV Consultancy is a specialized pharmacovigilance firm led by Dr. Med. Dnyaneshwar Arjun Sanap, MBA. The team provides end-to-end PV and QPPV services across the product lifecycle, from clinical development through post-marketing, with a particular focus on complex, oncology-driven portfolios.

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Core Services & Engagement Models

  • EU/UK QPPV Services: Provision of experienced EU and UK QPPV leadership, including deputy and local safety contact support, aligned with evolving regulatory expectations.
  • PV System Build & Operations: Design, implementation, and ongoing optimization of global PV systems - from database selection and validation to SOP frameworks and team training.
  • Audits, Inspections & CAPA: End-to-end support for PV audits and health authority inspections, including gap assessments, mock inspections, CAPA planning, and execution oversight.
  • Aggregate Reporting & Signal Management: Authoring and review of PSURs/PBRERs, DSURs, and other aggregate reports, coupled with robust signal detection and risk evaluation processes.
  • Flexible Engagement Models: Project-based, retainer, and embedded/seconded QPPV models to match sponsor scale, maturity, and geography.

How DSPV Works with AyurDatta

Integrated oncology programs
DSPV supports AyurDatta-led oncology and hematology studies by providing QPPV oversight, signal management, and PV system governance aligned with complex trial designs.
Safety-by-design strategy
PV considerations are embedded early in protocol and program design, ensuring that safety data collection, monitoring, and aggregate reporting are fit-for-purpose from the outset.
KOL-linked PV advisory
Through AyurDatta's expert network, DSPV integrates clinical KOL input into signal interpretation, benefit-risk assessment, and risk minimization planning.

Ideal Use Cases

  • Biotechs preparing to appoint their first EU/UK QPPV and stand up a compliant PV system.
  • Oncology sponsors scaling from early-phase to pivotal trials who need stronger global PV infrastructure.
  • Companies entering new regions (EU, UK, Canada) that require local PV representation and rapid regulatory alignment.
  • Mature organizations seeking an external review or audit of existing PV systems and processes.

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