GLOBAL CRO SUPPORT

Be it early or late phase clinical research, we focus on delivering highest level of data integrity and regulatory conformance across Biopharma, Medical devices and Consumer Health care globally

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EXCEPTIONAL REGULATORY COMPLIANCE

Successfully cleared 32+ USFDA inspections along with numerous other audits by major regulatory authorities worldwide

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WORLD-CLASS INFRASTRUCTURE

Providing services for BA/BE in PK/PD/CE, and Phase I trials

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COMMITMENT TO EXCELLENCE:

Trusted partner in accelerating research and development across Biologics, Biosimilars, Bio Betters, and more

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QUALITY ASSURANCE AND QUALITY CONTROL

Rich expertise in delivering QA/QC milestones such as Intra-Vitro Release Testing (IVRT) / Intra-Vitro Performance Testing (IVPT), NG Tube, Inhalers, and BCS Biowaivers

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Our Journey

Milestone

  • Inception of Raptim Research, Navi Mumbai

Our Journey

Milestone

  • Successfully cleared first 2 USFDA Inspections

Our Journey

Milestone

  • Initiated Clinical Trials Services (Phase II-IV)

Our Journey

Milestone

• Crossed 1000 pivotal BE Studies
• Started In-Vitro services

Our Journey

Milestone

• Added 125 beds at Gandhinagar facility
• UK MHRA Inspection

Our Journey

Milestone

  • Cleared 3 Unannounced USFDA Inspections

Our Journey

Milestone

• F2F study through Covid pandemic
• Large Clinical Trials of 900+ patients
• Cleared WHO Inspection

Our Journey

Milestone

• Successfully cleared 27th USFDA Inspection
(BE and IVPT)

Our Journey

Milestone

• Successfully cleared 31st USFDA Inspection
(BE, IVPT and Pt BE studies)
• 5 IVPT studies received USFDA approval
• Crossed 3000+ BE Studies

Our Journey

Milestone

• Total capacity reaches 390 Beds
• DCGI Approval for 12 Bed Phase I facility in Mumbai
• DCGI Approval for 38 beds for BA/BE studies
• GCC Approval

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Services

A global CRO for end-to-end clinical excellence, committed to delivering cutting-edge and reliable solutions to revolutionize the field of medicine. Discover our full range of accredited services and let us help you achieve your research goals!

BA/BE

  • Healthy Subject (Bioequivalence & Bioavailability) Studies, Pharmacokinetics (PK), Pharmacodynamics (PD) studies
  • Patient Based PK/PD and Clinical Endpoint (CE) Studies

In-Vitro Studies

  • In-vitro Release Rate Test (IVRT) & In-vitro Permeability Test (IVPT)
  • In-vitro binding Studies
  • BCS Biowaiver Studies
  • Inhalers studies

 

Special Studies

  • In Vivo Tape Stripping
  • In Vivo Dermal Microdialysis
  • Skin Blanching studies
  • Skin Irritation and sensitization test
  • Glucose clamp Studies

Clinical Trials

  • Early Phase Clinical trials
  • Patient based PK/PD/CE studies
  • Phase II-III Clinical trials
  • Phase IV / Post marketing and related studies

Unlock the full potential of your pharmaceutical research with the Raptim Research lab

At Raptim Research Lab, we are committed to propelling your pharmaceutical projects to new heights with our comprehensive bioanalytical method development and validation services. Trusted by industry leaders, our portfolio features over 600 meticulously validated methods, marking us as a frontrunner in bioanalytical solutions.

Why Choose Raptim Research ?

Expertise

Tailored
Solutions

Regulatory Compliance

Explore Our Assay Library

Dive into our extensive library of assays to discover how we can enhance your research efficiency and outcomes. Partner with us to leverage our proven track record and expertise for your success.

Regulatory Inspections

Raptim Insights

Your Source for Clinical Research Insights

Bioavailability and Bioequivalence: Why They Matter in Drug Development

Bioavailability and bioequivalence are critical concepts in the field of pharmacokinetics and play an essential role in drug development and regulatory approval. Understanding these concepts ...

Best Practices for Designing Effective Clinical Drug Trials: Tips and strategies for successful trial design

The journey from a promising molecule or medical device to a life-changing therapy is abundant with challenges. At the heart of this journey lies the ...

The Role of CROs in Development of Medicine: How CROs Have Shaped and Supported Medical Advancements

Have you ever wondered how life-saving drugs go from the lab to your pharmacy? While scientists and doctors are often in the spotlight, there’s a ...
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