2. Content About Us What do we do ? What are our objectives ? What do we Offer ? Some of Our Client List. Next Steps
3. About Us Based in Montreal, proGamma was incorporated in 1985 as proGamma Science and Engineering Corporation, the name was changed to the present one in 1988. Provide implementation consulting and professional training in the following major divisions for the Pharmaceutical industry : 1.Quality assurance and Regulatory Affairs 2.Pharmaceutical Technical Operations 3. Quality System Management (ISO 9000)
5. Quality Control and Regulatory Affairs Preparation and filing of submissions for prescription and non-prescription drugs, biologics, veterinary products & medical devices INDs, NDSs, S/NDSs, A/NDSs Chemistry and Manufacturing Preparation of CSCM forms for IND/NDS/NC filings; DMFs and PMFs ,site Ref.file in compliance with current standards; Establishment License Applications.
12. Technology Transfer Identify technologies of market interest. Identify new product opportunities for corporate or brand expansion. Develop acquisition plans and timetables. Support product formulation, medical device, and in-vitro diagnostic test development Develop product/technology transfer suitability information. Provide creative support for product design. Perform patent searches
13. Validation Services Conduct 21CFR11 evaluations of computer systems Develop protocols for IQ,OQ and PQ Develop and prepare necessary documentation Conduct computer hardware and software validation Analytical method validation Product process validation studies
14. Pharmaceutical ProductDevelopment Design and perform Optimization studies Assist improving manufacturing for sterile and non-sterile products Provide assistance to develop new product formulations for non-sterile and sterile products.
15. Analytical Instrumentation :Validation, Consulting and Automation HPLC, GC, GC/MS, LC/MS/MS systems qualification Chemical and microbiological Laboratory Design Laboratory Automation Analytical method development. Computer -Assisted Chromatography
16. Technical Training We offer complete training in : 1. Pharmaceutical technical operations 2.Quality Systems On-site training as well as Technical Conferences Pharmaceutical Process Validation courses Computer System Validation courses Focus Pro Workshops : specialized subject-3hr. sections Verify our web site for more details : www.progamma.ca
17. What are our Objectives? Provide the client with Excellent service and best possible cost. Long-term loyal partnership with our clients Employ best qualified professionals Provide high quality reports
18. What do we offer ? Prompt high quality service Best time estimates for submission Monthly status reports Confidential service QA documentation storage Documentation support /as per TPD /FDA / EC Accurate cost estimate/no hidden costs
