際際滷

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

More Related Content

Actimus Bio

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

Editor's Notes

  • #2: Actimus Bio Your Partner For Drug Development
  • #3: Actimus Bio Your Partner For Drug Development
  • #4: Actimus Bio Your Partner For Drug Development
  • #5: Actimus Bio Your Partner For Drug Development
  • #6: Actimus Bio Your Partner For Drug Development
  • #7: Actimus Bio Your Partner For Drug Development
  • #8: Actimus Bio Your Partner For Drug Development
  • #9: Actimus Bio Your Partner For Drug Development
  • #10: Actimus Bio Your Partner For Drug Development
  • #11: Actimus Bio Your Partner For Drug Development
  • #12: Actimus Bio Your Partner For Drug Development
  • #13: Actimus Bio Your Partner For Drug Development
  • #14: Actimus Bio Your Partner For Drug Development
  • #15: Actimus Bio Your Partner For Drug Development
  • #16: Actimus Bio Your Partner For Drug Development
  • #17: Actimus Bio Your Partner For Drug Development
  • #18: Actimus Bio Your Partner For Drug Development