Drug Registration
Brandex is the fastest growing firm in Pakistan. It is growing vertically as well as horizontally by entering into almost every sector of industry. Now Brandex’s expertise is holding ground in the field of drug registration with the help of Drug Regulation Authority of Pakistan.
DSL(drug sale license),DRAP(Drug Regulatory Authority Of Pakistan),Registration of products, etc. for importers, manufacturers and traders.
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:
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- CTD / eCTD Preparation and Compilation of Products for Local Registration Submissions
- ACTD/CTD / eCTD Preparation and Compilation of Products for Export Countries Registration Submissions
- CTD / eCTD Preparation and Compilation for WHO Prequalification of Products
- 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
- Assist in execution of BE / BA Studies as per International Standard Guidelines
- Designing and Preparation of Biowaivers Justifications for those Molecules where WHO recommends Biowaiver as International Standard Guidelines
- ACTD/CTD / eCTD Screening Approval from WHO for Product Prequalification and PIC/S Qualification from PIC/S participating countries
- CTD / eCTD Efficacy Part Assessment Approval from WHO for Product Prequalification
- CTD / eCTD Quality Part Assessment Approval from WHO for Product Prequalification
- Assist in correspondence with WHO PQ Team
- LIF Preparation and Compilation for WHO Prequalification of Quality Control Laboratory as WHO Guidelines
- LIF Screening and Assessment Approval from WHO for QC Lab Prequalification
- Preparation of Site Master File as per International Standard Guidelines
- Preparation of Quality Manual as per International Standard Guidelines
- Creation and Deployment of Quality Management System across the Facility as per International Standard Guidelines
- Assist in WHO Inspection of the Plant for Product Prequalification and PIC/S Qualification Inspection conduct by PIC/S Participating countries regulatory authorities
- Assist in WHO Inspection of the Lab for QC Lab Prequalification
- Assist in Preparation of CAPA of Inspection Report
- Assist in Closure of CAPA and its Verification in timely manner
- Conduct of comprehensive Trainings & Workshops to provide complete awareness on QMS subjects, Inspection Readiness, Lean Concepts & Tools, Six Sigma and Value Stream Mapping (VSM)
- Evaluation of wastes and variations exist in current processes and provide solutions for Process Optimization
- Evaluation of deficiencies in existing QMS and provide their rectification plan in the light of International Standard Guidelines
- 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
- Assist in Lab Instruments Performance Qualification and preparation of their Reports
- Conduct of comprehensive Trainings and Workshops on all subjects related to Analysis and Operations of Lab Instruments
- Assist in the Deployment of ERP Systems, Electronic QMS and LIMS systems
- Assist in writing and preparation of Script, Protocols and Reports for Validation of ERP Systems, Electronic QMS and LIMS Systems
- 28) Assist in Data Migration of existing data into newly acquired ERP Systems, Electronic QMS and LIMS Systems
- Designing of documents, formats and templates to furnish data as international standard guidelines
- Conduct of comprehensive Trainings and Workshops on Root Cause Analysis and Investigation Tools
- Perform Gap Assessment for Facility cGMP Compliance and provide solutions in making the Facility fully compliant with cGMP International Standard Guidelines
- Review and perform Gap Assessment to identify deficiencies in the existing Layout of Facility in the light of requirements as per International Standard Guidelines
- Provide solutions to fill the gaps identified in the existing Layout of Facility
- Assist in the Development of New Facility Layout in the light of requirements as per International Standard Guidelines.
Contact
- B4-828 St#1, Chungi No 8, Near NBP Muslim Town, Rawalpindi, Pakistan
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+923360015004
+923360015009 - info@brandex.pk support@brandex.pk
