dpse.regulatory@gmail.com
+91 9561350405
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Services

Our Services

What We Offer for You

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Regulatory Services

  • End to end Regulatory Strategy and submission
  • eCTD & SPL
  • DMF Management
  • Dossier Preparation & Submission
  • Life Cycle Management
  • Regulatory Support Services
  • ANDAs dossiers preparation and submission
  • MSDS
  • PDE/OEL reports in accordance to EU guideline.
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Pharma Project Management

  • End to end Preclinical Services for product development and Marketing authorization
  • Selecting and negotiation of cost and timeline with Preclinical CROs
  • Review of draft study plan and reports
  • Impurity qualification toxicology studies as per ICH guideline
  • Writing executive summary for regulatory submission.
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Risk Assessment

  • Risk assessment of Excipients
  • Risk assessment and scientific writeup for Impurity/Degradation/Leachable/Extractable
  • Risk assessment for Elemental impurity as per ICHQ3D.
  • Out of specification (OOS) justification 
  • BET report for Large Volume Parenteral (LVP).
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Pharmacovigilance

  • PSUR/PBRER R1 and R2 format: Periodic safety update reports
  • PADER - US safety reports
  • Risk Assessment Plan (RMP)
  • Signal Management
  • Health Hazard Assessment Reports
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Product Development

  • Product Development
  • Preparation of Investigation Brochure
  • Preparation of PIL, SmPC, PI
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Training

  • Regulatory Training
  • GMP Training
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Our Pricing

Our Pricing Plans

Basic Plan

$30/mo

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Business

$40/mo

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Professional

$60/mo

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Basic Plan

$300/mo

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Business

$400/mo

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Professional

$600/mo

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How It Works

DSPE Consultancy provides end to end regulatory services starting from gap analysis of the dossier, product development guidance, regulatory strategy, scientific writing of dossier, submission to health authority, query response and approval.

What type of challenge are you facing? Let’s talk

dpse.regulatory@gmail.com +91 9561350405

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