About Us

Our Success Story

DPSE consultancy founded in Year 2012, by Clinical and Regulatory Professional Mrs. Neelprabha Rathore who have been associated with some of the known pharmaceutical companies for close to a decade now.

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. Our services cover APIs and Formulations for ROW and Emerging Markets as well. We have supported our clients to obtain successful regulatory approvals of their APIs and/or Finished Products across the globe viz., EU, CDE-China, ROW, CIS, ...Read More

Mrs. Neelprabha Rathore

Founder & CEO

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24/7 Suport Team

 

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Quality Services

 

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Budget Friendly

Our Services

What We Offer for You

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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We’d Love to Here from You Our Teams Are Here to Help

9 Years of Experience in the Industry

We are Uncompetitive in Consulting Solution Around the world.

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25+

Clients

25+

Countries

15+

Professionals

570+

Projects Completed

News & blogs

Latest News & Blogs

Careers

Current Opening

Medical Writer, Regulatory Associates

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Full Time

Medical Writter
  • Region: Europe and ROW market
  • Department: Regulatory Affairs
  • Location: Kalyan, Thane District, Mumbai, Maharashtra, India
  • Yrs of exp : 5 yrs+

Full Time

Regulatory Associates
  • Region: Europe and ROW market
  • Department: Regulatory Affairs
  • Location: Kalyan, Thane District, Mumbai, Maharashtra, India
  • Yrs of exp : 5 yrs+ Handling the DMF and Dossier Preparation

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