ProGammaScience Corporation is a consulting firm based in Montreal that has been providing quality assurance, regulatory affairs, and technical operations services to the pharmaceutical industry since 1985, including assistance with submissions, GMP compliance, analytical method validation, product development, and technical training. The company aims to deliver excellent client service and documentation support at the best possible cost through its team of qualified professionals. Some of ProGammaScience's clients include major pharmaceutical companies like Abbott, AstraZeneca, Merck, Novartis, and Pfizer.

1. proGammaScience CorporationWe Deliver Achievement And Excellence

2. ContentAbout UsWhat do we do ?What are our objectives ?What do we Offer ? Some of Our Client List.Next Steps

3. About UsBased 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 Affairs2.Pharmaceutical Technical Operations3. Quality System Management (ISO 9000)

4. What do we do ?

5. Quality Control and Regulatory AffairsPreparation and filing of submissions for prescription and non-prescription drugs, biologics, veterinary products & medical devices INDs, NDSs, S/NDSs, A/NDSsChemistry and Manufacturing Preparation of CSCM forms for IND/NDS/NC filings; DMFs and PMFs ,site Ref.filein compliance with current standards; Establishment License Applications.

6. Good Laboratory Practice and QASet-up and management of research laboratories in compliance with industry and government guidelinesWill Assume complete quality control function for companies without QC/QA :

7. Release products on-time for market.

8. Comprehensive accurate reporting.

9. Problem solving / recommendations.

10. Complete product traceability.

11. Complete SOPs /SOP manualGMP ComplianceGMP audits, vendor/ supplier audits, policy procedure review and developmentGood Clinical Trials Practice

12. Technology TransferIdentify technologies of market interest.Identify new product opportunitiesfor corporate or brand expansion.Develop acquisition plans and timetables.Support product formulation, medical device, and in-vitro diagnostic test developmentDevelop product/technology transfer suitability information.Provide creative support for product design.Perform patent searches

13. Validation ServicesConduct 21CFR11 evaluations of computer systems Develop protocols for IQ,OQ and PQ Develop and prepare necessary documentation Conduct computer hardware and software validationAnalytical method validationProduct process validation studies

14. Pharmaceutical ProductDevelopmentDesign and perform Optimization studiesAssist improving manufacturing for sterile and non-sterile productsProvide assistance to develop new product formulations for non-sterile and sterile products.

15. Analytical Instrumentation :Validation, Consulting and AutomationHPLC, GC, GC/MS, LC/MS/MS systems qualificationChemical and microbiological Laboratory DesignLaboratory AutomationAnalytical method development.Computer -Assisted Chromatography

16. Technical TrainingWe offer complete training in :1. Pharmaceutical technical operations2.Quality SystemsOn-site training as well as Technical ConferencesPharmaceutical Process Validation coursesComputer System Validation coursesFocus Pro Workshops : specialized subject-3hr. sectionsVerify 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 clientsEmploy best qualified professionalsProvide high quality reports