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Raptim Research Ltd.

Raptim Research Ltd. Raptim Research Ltd. Your CRO – for all your Clinical Research Requirements. Raptim Vision To achieve the fastest path to regulatory, scientific & clinical approvals of drugs, biologics and medical devices

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Raptim Research Ltd.

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  1. Raptim Research Ltd. Raptim

  2. Raptim Research Ltd. Your CRO – for all your Clinical Research Requirements. Raptim Vision To achieve the fastest path to regulatory, scientific & clinical approvals of drugs, biologics and medical devices while maintaining the highest ethical and scientific standards. Raptim

  3. RAPTIM - QUALITY POLICY • Raptim Is Committed To Provide The Highest Quality Services As Per National & International Standards In The Following Areas : • Clinical Research • Pharmacokinetic Studies (BA / BE) • Pharmacodynamic Studies • Phase II / Phase III Trials Raptim

  4. RAPTIM - QUALITY POLICY • We Assure • Consistently Meeting or Exceeding Our Customer’s Expectations For Quality & Performance of Projects • Use of Validated Methodology • Timely Submission of Reports and Regulatory Submissions • Continuous Improvement Of Our Systems • Trained Personnel Raptim

  5. RAPTIM - FACILITY Clinical & Bioanalytical Facilities Under One Roof SITE ADDRESS: Raptim Research Ltd. A – 226, Mahape MIDC Navi Mumbai – 400 701 India Raptim

  6. RAPTIM - THE CORE TEAM • Dr. Rajen Shah Bachelor of Pharmacy and PhD from University of Maryland, US. More than 14 years of research experience with Novartis in US and Basle. • Viraj Shah Masters in Business Administration with more than 25 years of experience in Finance and Management in USA & UK. • Dr. Asmita Nimkar , Head - Quality Assurance Masters in Science and PhD in Analytical Chemistry, more than 15 years of experience with Biopharmaceutical Studies. Broad experience in all aspects of BA/BE studies with other CROs. All members of the core team have been Involved in BA/BE studies, for various regulatory submissions, including for the US FDA. Raptim

  7. RAPTIM - SERVICES • Clinical Trials • Protocol Design • CRF Design - Case Report Form (CRF) • Site feasibility studies • Investigator and Site Selection • Patient Enrollment • Study Monitoring and Data Collection • Regulatory Affairs • Ethics Committee submission • Project Management • Quality Assurance Raptim

  8. RAPTIM - SERVICES BA/BE Studies • Fasting Studies • Food Effect studies • Multiple dose /Steady State Studies • Bio-Analytical Method Development/Validation • Special Population Raptim

  9. RAPTIM - SERVICES • Drug Interaction Studies • Dose escalation studies • Special capabilities in Dermal Equivalence Studies Raptim

  10. RAPTIM – THE GLOBAL EXPERIENCE Raptim has filed • 2 ANDA Submissions • 2 Australia TGA Submissions • 1 Canada TPD Submission • Completed 75 BA/BE studies • Developed 70 Bioanalytical methods WE STAND COMMITTED TO QUALITY SYSTEMS AND QUALITY DOCUMENTATION Raptim

  11. RAPTIM - OUR SITE Level 0 Level 1

  12. RAPTIM - INFRASTRUCTURE SALIENT FEATURES OF RAPTIM’S CAPABILITIES A Well Equipped Bio- Analytical Laboratory • LC/MS/MS Systems • HPLC Systems • UV / Fluorescence Detectors • pH Meter • SPE Manifold • Nitrogen Evaporator • Ultrasonicator • Centrifuges • Vortex Mixers • Dissolution Apparatus • UPS and Generator Power Back up Raptim

  13. RAPTIM - INFRASTRUCTURE • 36 Bed Capacity with Dining and Recreation Facilities • Screening Area • Well equipped Emergency Care Unit • Dedicated Sample Collection and Processing Area • Staging Area for Human Subjects • Screening Area • Change Rooms • Separate Area For Subjects’ Housing for Male and Female Subjects Salient Features of Raptim’s Capabilities Raptim

  14. RAPTIM - INFRASTRUCTURE • Biometrics: All Subjects have their thumb print taken for secure identification • Bar Codes: All subjects and their blood samples are bar coded to eliminate misidentification of samples • Online Documentation: All data entries done online. Seamless transfer of data into Statistical Software and into Study Reports. • Customized IT system: All processes driven by this in house system Raptim

  15. RAPTIM - AUDITS & APPROVALS APPROVED BY • Drugs Controller General Of India AUDITS – INDEPENDANT CONSULTANTS • Audited for TPD, Canada compliance (Mr. Barry Poole) • Audited for US FDA compliance (Dr. Henry Lau and Mr. Doyle Smith) • Audited for TGA, Australia compliance (Mr. Don Friederich, Ms, Jane Calambi) Raptim

  16. RAPTIM -VISION 2010 • Leader In BE Studies • International Regulatory Approvals • Human Care Management • Excellence in GCP & GLP Compliance • Global Presence Raptim

  17. RAPTIM - VISION 2010 Raptim’s Strengths • Backed with experience of successful US FDA and other Audits Key personnel who have been at backbone of several US FDA submissions, have given us a unique ability to deliver the best. • Complemented by well equipped Clinical and Bio-analytical Facilities Raptim

  18. Thank You Raptim

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