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Brand Registration

Drug Registration

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Orakser's is the fastest growing firm in Pakistan. It is growing vertically as well as horizontally by entering into almost every sector of industry. Now ORAKSER’s expertise is holding ground in the field of drug registration with the help of Drug Regulation Authority of Pakistan.

Provides resplendent services to resolve your problems on a rapid pace by simplifying the complexities in your processes and helps to eliminate elongations and troublesomeness from your following ventures:

  1. CTD / eCTD Preparation and Compilation of Products for Local Registration Submissions
  2. ACTD/CTD / eCTD Preparation and Compilation of Products for Export Countries Registration Submissions
  3. CTD / eCTD Preparation and Compilation for WHO Prequalification of Products
  4. Assist in Designing and Preparation of BE / BA Protocols as per International Standard Guidelines for those Molecules where BE /BA study is recommended by WHO
  5. Assist in execution of BE / BA Studies as per International Standard Guidelines
  6. Designing and Preparation of Biowaivers Justifications for those Molecules where WHO recommends Biowaiver as International Standard Guidelines
  7. ACTD/CTD / eCTD Screening Approval from WHO for Product Prequalification and PIC/S Qualification from PIC/S participating countries
  8. CTD / eCTD Efficacy Part Assessment Approval from WHO for Product Prequalification
  9. CTD / eCTD Quality Part Assessment Approval from WHO for Product Prequalification
  10. Assist in correspondence with WHO PQ Team
  11. LIF Preparation and Compilation for WHO Prequalification of Quality Control Laboratory as WHO Guidelines
  12. LIF Screening and Assessment Approval from WHO for QC Lab Prequalification
  13. Preparation of Site Master File as per International Standard Guidelines
  14. Preparation of Quality Manual as per International Standard Guidelines
  15. Creation and Deployment of Quality Management System across the Facility as per International Standard Guidelines
  16. Assist in WHO Inspection of the Plant for Product Prequalification and PIC/S Qualification Inspection conduct by PIC/S Participating countries regulatory authorities
  17. Assist in WHO Inspection of the Lab for QC Lab Prequalification
  18. Assist in Preparation of CAPA of Inspection Report
  19. Assist in Closure of CAPA and its Verification in timely manner
  20. Conduct of comprehensive Trainings & Workshops to provide complete awareness on QMS subjects, Inspection Readiness, Lean Concepts & Tools, Six Sigma and Value Stream Mapping (VSM)
  21. Evaluation of wastes and variations exist in current processes and provide solutions for Process Optimization
  22. Evaluation of deficiencies in existing QMS and provide their rectification plan in the light of International Standard Guidelines
  23. Conduct of comprehensive Trainings and Workshops on following:
    • Product Formulation, Tech Transfer, Validations and QbD (Quality By Design)
    • Selection and Qualification of API Manufacturers
    • Review and thorough Assessment of DMFs of APIs
    • Analysis of Products and Raw Materials complying with International Compendia
    • Analysis of Products and Raw Materials complying with In-house Specifications for molecules not published in any International Compendia
    • Preparation of COAs
    • Validation and Verification of Analytical Methods of Products and Raw Materials as per International Standard Guidelines
    • Writing and preparation of Validation Protocols and Reports and conclusions
    • Microbiological Analysis of Products and Raw Materials
    • Writing and Preparation of Microbiological Analysis Reports and conclusion
  24. Assist in Lab Instruments Performance Qualification and preparation of their Reports
  25. Conduct of comprehensive Trainings and Workshops on all subjects related to Analysis and Operations of Lab Instruments
  26. Assist in the Deployment of ERP Systems, Electronic QMS and LIMS systems
  27. Assist in writing and preparation of Script, Protocols and Reports for Validation of ERP Systems, Electronic QMS and LIMS Systems
  28. 28) Assist in Data Migration of existing data into newly acquired ERP Systems, Electronic QMS and LIMS Systems
  29. Designing of documents, formats and templates to furnish data as international standard guidelines
  30. Conduct of comprehensive Trainings and Workshops on Root Cause Analysis and Investigation Tools
  31. Perform Gap Assessment for Facility cGMP Compliance and provide solutions in making the Facility fully compliant with cGMP International Standard Guidelines
  32. Review and perform Gap Assessment to identify deficiencies in the existing Layout of Facility in the light of requirements as per International Standard Guidelines
  33. Provide solutions to fill the gaps identified in the existing Layout of Facility
  34. Assist in the Development of New Facility Layout in the light of requirements as per International Standard Guidelines.