Progamma Us

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About proGamma

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Progamma Us

  1. 1. proGammaScience Corporation<br />We Deliver Achievement And Excellence<br />
  2. 2. Content<br />About Us<br />What do we do ?<br />What are our objectives ?<br />What do we Offer ? <br />Some of Our Client List.<br />Next Steps<br />
  3. 3. About Us<br />Based in Montreal, proGamma was <br /> incorporated in 1985 as proGamma Science and Engineering Corporation, the name was changed to the present one in 1988.<br />Provide implementation consulting and professional training in the following major divisions for the Pharmaceutical industry :<br />1.Quality assurance and Regulatory Affairs<br />2.Pharmaceutical Technical Operations<br />3. Quality System Management (ISO 9000)<br />
  4. 4. What do we do ?<br />
  5. 5. Quality Control and Regulatory Affairs<br />Preparation and filing of submissions<br /> for prescription and non-prescription <br />drugs, biologics, veterinary products<br /> & medical devices <br /> INDs, NDSs, S/NDSs, A/NDSs<br />Chemistry and Manufacturing <br />Preparation of CSCM forms for <br />IND/NDS/NC filings; DMFs and PMFs ,site Ref.file<br />in compliance with current standards;<br /> Establishment License Applications.<br />
  6. 6. Good Laboratory Practice and QA<br />Set-up and management of research<br /> laboratories in compliance with industry and government guidelines<br /><ul><li>Will Assume complete quality control function for companies without QC/QA :
  7. 7. Release products on-time for market.
  8. 8. Comprehensive accurate reporting.
  9. 9. Problem solving / recommendations.
  10. 10. Complete product traceability.
  11. 11. Complete SOPs /SOP manual</li></li></ul><li>GMP Compliance<br />GMP audits, vendor/ supplier audits,<br /> policy procedure review and development<br />Good Clinical Trials Practice<br />
  12. 12. Technology Transfer<br />Identify technologies of market interest.<br />Identify new product opportunities<br />for corporate or brand expansion.<br />Develop acquisition plans and timetables.<br />Support product formulation, medical device, <br /> and in-vitro diagnostic test development<br />Develop product/technology transfer <br /> suitability information.<br />Provide creative support for product design.<br />Perform patent searches<br />
  13. 13. Validation Services<br />Conduct 21CFR11 evaluations of computer systems <br />Develop protocols for IQ,OQ and PQ <br />Develop and prepare necessary documentation <br />Conduct computer hardware and software validation<br />Analytical method validation<br />Product process validation studies<br />
  14. 14. Pharmaceutical ProductDevelopment<br />Design and perform Optimization<br /> studies<br />Assist improving manufacturing<br /> for sterile and non-sterile products<br />Provide assistance to develop new<br /> product formulations for non-sterile and sterile products.<br />
  15. 15. Analytical Instrumentation :Validation, Consulting and Automation<br />HPLC, GC, GC/MS, LC/MS/MS systems qualification<br />Chemical and microbiological<br /> Laboratory Design<br />Laboratory Automation<br />Analytical method development.<br />Computer -Assisted Chromatography<br />
  16. 16. Technical Training<br />We offer complete training in :<br />1. Pharmaceutical technical operations<br />2.Quality Systems<br />On-site training as well as Technical Conferences<br />Pharmaceutical Process Validation courses<br />Computer System Validation courses<br />Focus Pro Workshops : specialized subject-3hr. sections<br />Verify our web site for more details : www.progamma.ca<br />
  17. 17. What are our Objectives?<br />Provide the client with Excellent service and best possible cost.<br /> Long-term loyal partnership with our clients<br />Employ best qualified professionals<br />Provide high quality reports<br />
  18. 18. What do we offer ?<br />Prompt high quality service<br />Best time estimates for submission<br />Monthly status reports<br />Confidential service<br />QA documentation storage<br />Documentation support /as per TPD /FDA / EC<br />Accurate cost estimate/no hidden costs<br />
  19. 19. Some of our clients list<br />Abbott Labs Ltd , Aeterna Labs , Astra-Zenica ,Aventis Pharma Inc., Agilent Technologies , Biochem Pharma , Biomatrix Medical , Confab Labs., Church & Dwight Canada,Delmar Chemicals , Dermtek Pharmaceuticals Ltd., Dimethaid Manufacturing ,Draxis Pharma Inc. Ferga Inc., Galderma Production, Health Canada (TPD), Merck-Frosst Canada ,Novopharm LTD , Novartis Pharmaceuticals ,Omega Valtec Ltd. , Pharma Science, Pfizer Canada ,ProDoc,Riva Labs ,Schering-Plough, Medical, Sterigen, radiopharm Inc, Tyco HealthCare,Valeant Pharmaceutical International,Validapro Inc., Validation Technologies Inc.,Wyeth Canada.<br />
  20. 20. Next Steps<br />Provide an on-site estimation of project<br />Proposal<br />Customer Approval<br />Contract<br />
  21. 21. Contact Us<br />Tel: (514) 695-8622<br />Fax: (514) 697-4355<br />E-mail: infoteck@progamma.ca<br />

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