Actimus Biosciences

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  • Actimus Bio Your Partner For Drug Development
  • Actimus Bio Your Partner For Drug Development
  • Actimus Bio Your Partner For Drug Development
  • Actimus Bio Your Partner For Drug Development
  • Actimus Bio Your Partner For Drug Development
  • Actimus Bio Your Partner For Drug Development
  • Actimus Bio Your Partner For Drug Development
  • Actimus Bio Your Partner For Drug Development
  • Actimus Bio Your Partner For Drug Development
  • Actimus Bio Your Partner For Drug Development
  • Actimus Bio Your Partner For Drug Development
  • Actimus Bio Your Partner For Drug Development
  • Actimus Bio Your Partner For Drug Development
  • Actimus Bio Your Partner For Drug Development
  • Actimus Bio Your Partner For Drug Development
  • Actimus Bio Your Partner For Drug Development
  • Actimus Bio Your Partner For Drug Development
  • Actimus Biosciences

    1. 1. <ul><li>Actimus Biosciences Pvt Ltd </li></ul><ul><li>Corporate Overview </li></ul>07/24/10 www.actimusbio.com
    2. 2. <ul><li>Founded By </li></ul><ul><li>Ramnath Reddy  </li></ul><ul><li>Chairman and Managing Director </li></ul><ul><li>B.S (Chemical Engineering), </li></ul><ul><li>M.S. (Biomedical Engineering) University of Massachusetts, Boston, MA. </li></ul><ul><li>Research Fellow at the Department of Molecular Pharmacology, </li></ul><ul><li>Physiology & Biotechnology (MPPB), Brown University, Providence, RI. </li></ul><ul><li>Ramnath Reddy brings his vast experience in the field of Healthcare, pharmaceutical and medical industries to Actimus Bio. </li></ul><ul><li>He previously worked in several senior management roles like Global Head, </li></ul><ul><li>Business Development for top five CROs in the Drug Discovery and </li></ul><ul><li>Development, He is on the board of various companies involved in the Life </li></ul><ul><li>Sciences field both in India and United States </li></ul>07/24/10 www.actimusbio.com
    3. 3. <ul><li>Global Presence </li></ul>07/24/10 www.actimusbio.com
    4. 4. <ul><li>Actimus Bio Snapshots </li></ul><ul><ul><li>Incorporated at Visakhapatnam in 2005 </li></ul></ul><ul><ul><li>Approved by Drugs Controller General of India (DCGI) </li></ul></ul><ul><ul><li>Registered as 100 % EOU with Visakhapatnam Special Economic Zone (VSEZ) </li></ul></ul><ul><ul><li>Professionally Managed Private Limited Company </li></ul></ul><ul><ul><li>Occupied Area : 25,000 Sq. Ft Facility </li></ul></ul><ul><ul><li>Executed More than 350 Studies </li></ul></ul>07/24/10 www.actimusbio.com
    5. 5. <ul><li>Facilities </li></ul><ul><li>Two Independent Clinics (72 Beds) with Modern Amenities </li></ul><ul><ul><li>Fully Equipped ICU </li></ul></ul><ul><ul><li>Axsym Serology & EM 360 Biochemical Analysers </li></ul></ul><ul><ul><li>Two API 3200 LC-MS/MS </li></ul></ul><ul><ul><li>Deep Freezers (-40 & -80°C) and Temperature Controlled Centrifuges </li></ul></ul><ul><ul><li>Data Back-up Devices </li></ul></ul><ul><ul><li>Micro Balances (Semi & Ultra) </li></ul></ul><ul><ul><li>Millipore Units for HPLC Grade water </li></ul></ul><ul><ul><li>Latest WinNonlin 5.2 & SAS 9.2 Software's and Archival </li></ul></ul>07/24/10 www.actimusbio.com
    6. 6. <ul><li>Value System </li></ul><ul><li>Actimus Bio takes pride in being Rapid, Responsive and Reliable: </li></ul><ul><ul><li>Rapid in taking Projects through from Initiation to the Final Report </li></ul></ul><ul><ul><li>Responsive in Feeding Back to Clients on the progress of their Projects </li></ul></ul><ul><ul><li>Reliable in the Quality of our work. </li></ul></ul>07/24/10 www.actimusbio.com
    7. 7. <ul><li>Quality System </li></ul><ul><li>We are concerned about your outcomes….. </li></ul><ul><ul><li>5000 + Strong volunteer database </li></ul></ul><ul><ul><li>Lesser Metabolic Variation </li></ul></ul><ul><ul><li>In Visakhapatnam we are the only CRO operating so that Quality Volunteers Recruitment is Possible </li></ul></ul>07/24/10 www.actimusbio.com
    8. 8. <ul><li>Services Offering </li></ul><ul><li>Actimus Bio offers an extensive range of Clinical services including </li></ul><ul><ul><li>Study Design </li></ul></ul><ul><ul><li>Project Management </li></ul></ul><ul><ul><li>Medical Safety Monitoring </li></ul></ul><ul><ul><li>Biostatistics </li></ul></ul><ul><ul><li>Quality Assurance Auditing </li></ul></ul><ul><ul><li>Regulatory Submissions and Scientific Communications </li></ul></ul>07/24/10 www.actimusbio.com
    9. 9. <ul><li>Department Overview </li></ul><ul><li>Operating with… </li></ul><ul><ul><ul><li>Clinical Research Department </li></ul></ul></ul><ul><ul><ul><li>Bioanalytical Department </li></ul></ul></ul><ul><ul><ul><li>Quality Assurance Department </li></ul></ul></ul><ul><ul><ul><li>Pka and Statistical Department </li></ul></ul></ul><ul><ul><ul><li>Diagnostic Unit </li></ul></ul></ul><ul><ul><ul><li>Technical Support Department </li></ul></ul></ul><ul><ul><ul><li>Finance Department </li></ul></ul></ul><ul><ul><ul><li>H R and Administrative Department </li></ul></ul></ul><ul><ul><ul><li>Business Development Department </li></ul></ul></ul>07/24/10 www.actimusbio.com
    10. 10. <ul><li>Regulatory Compliance </li></ul><ul><li>All Equipments are 21 CFR PART 11 Compliant </li></ul><ul><li>Laboratory SOP’s Complaint with USFDA, ANVISA, ICH Guidelines </li></ul><ul><li>Strict Adherence to cGLP & cGCP </li></ul><ul><li>UPS Backup for Un-Interrupted Operation </li></ul><ul><li>Periodic Calibration (In-house & External) </li></ul><ul><li>Periodic Preventive Maintenance Check (Through Vendors) </li></ul><ul><li>Electronic Back-Up of DATA (Project Specific) and Proper Waste Disposal (Contract Vendor) </li></ul>07/24/10 www.actimusbio.com
    11. 11. <ul><li>Project Timeline </li></ul>07/24/10 www.actimusbio.com Document Development & Internal Approvals 2 Working Days Sponsor Review & Approval 2 Working Days IRB Submissions & Approval 3 Working Days DCGI Submissions & Approval 28 Working Days Project Initiation Approved Protocol 35-40 Days
    12. 12. <ul><li>IPR Protection </li></ul><ul><li>Management of IP – Philosophy </li></ul><ul><ul><li>We value client’s IP and Ensure its best protection </li></ul></ul><ul><ul><li>IP Solely belongs to client </li></ul></ul><ul><li>Systems and Measures </li></ul><ul><ul><li>Manual and electronic security in the premises </li></ul></ul><ul><ul><li>Separate team for each client </li></ul></ul><ul><ul><li>Employee confidentiality Agreement/Release policy & Stringent CDA </li></ul></ul><ul><ul><li>Specified NON DISCLOSURE period after release </li></ul></ul><ul><ul><li>Continuous employee training on confidentiality </li></ul></ul><ul><ul><li>SOP to handle IP </li></ul></ul><ul><ul><li>Coding of all project related documents </li></ul></ul>07/24/10 www.actimusbio.com
    13. 13. <ul><li>Partnering with Actimus Bio </li></ul><ul><ul><ul><li>5000+ Volunteer Data Base which is top most positive for Actimus Bio being only CRO in Vizag </li></ul></ul></ul><ul><ul><ul><li>Fastest Take-off time with the best clinical practices </li></ul></ul></ul><ul><ul><ul><li>Young Team with right competencies & an Excellent Experience </li></ul></ul></ul><ul><ul><ul><li>Trust-worthy Confidential Standards </li></ul></ul></ul><ul><ul><ul><li>Effective Functioning of IRB </li></ul></ul></ul><ul><ul><ul><li>Adherence to SOPs & Protocols </li></ul></ul></ul><ul><ul><ul><li>Reliable Subject Safety & Internal Processes </li></ul></ul></ul><ul><ul><ul><li>Committed Proprietary Data Protection </li></ul></ul></ul>07/24/10 www.actimusbio.com
    14. 14. <ul><li>Meeting Clients Requirement </li></ul><ul><li>Actimus ensures compliance at every level </li></ul><ul><ul><ul><li>72 Bed Facility for Conducting both Pilot and Pivotal Studies </li></ul></ul></ul><ul><ul><ul><li>Provide Efficient Project Management Services </li></ul></ul></ul><ul><ul><ul><li>Time Management for Robust Delivery </li></ul></ul></ul><ul><ul><ul><li>Strategic Management & Project Planning </li></ul></ul></ul><ul><ul><ul><li>Continuous Communication till Project Completion </li></ul></ul></ul><ul><ul><ul><li>Maximising Resource Flexibility </li></ul></ul></ul><ul><ul><ul><li>Gathers Population on a Case-by-Case basis </li></ul></ul></ul><ul><ul><ul><li>Volunteer Database Management </li></ul></ul></ul><ul><ul><ul><li>Comprehensive Bio-safety Program to Ensure Safety of Volunteers </li></ul></ul></ul><ul><ul><ul><li>Dietician for providing Study Specific Diet </li></ul></ul></ul>07/24/10 www.actimusbio.com
    15. 15. <ul><li>Approved Bioanalytical Methods </li></ul>07/24/10 www.actimusbio.com Carvedilol Naratriptan Repaglinide Hctz Pantoprazole Valsartan Imatinib Itraconazole Atorvastatin Eszopiclone Propranolol Hydroxy Itraconazole Venlafaxine Valacyclovir 4-Hydroxy Propranolol Rizatriptan O-Desmethyl Venlafaxine Aciclovir Respiridone Azithromycin Quetapine Tizanidine 9-Hydroxy Respiridone Aprepitent Lansoprazole Escitalopram Lercanidipine Ethambutol Valproic acid Sibutramine Desloratidine Pyrazinamide Metoprolol Desmethyl Sibutramine Cetrizine Ropinirole Aspirin Didesmethyl Sibutramine Alfuzosin Bupropion Indomethacin Irbesartan Oxcarbazipine Hydroxy bupropion Olanzapine Sildenafil 10-Hydroxy Oxcarbazipine Metformin Lamotrigin Desmethyl Sildenafil Isoniazid Irbersartan Esomeprazole Levitiracetam Mycophenolate Mofetil Riluzole
    16. 16. <ul><li>Contact Us </li></ul><ul><li>Mr. Y.K.Naidu </li></ul><ul><li>General Manager </li></ul><ul><li>Mobile : +91 96760 00400 </li></ul><ul><li>Email : [email_address] </li></ul><ul><li>Mr. Ningappa Vathare </li></ul><ul><li>Executive – Business Development </li></ul><ul><li>Mobile : +918008222278 </li></ul><ul><li>Email : [email_address] </li></ul>07/24/10 www.actimusbio.com
    17. 17. <ul><li>Thank You </li></ul><ul><li>[email_address] </li></ul>07/24/10 www.actimusbio.com

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