1 / 18

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

idola-yang
Télécharger la présentation

Raptim Research Ltd.

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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

More Related