Bangladesh Pharmaceutical companies need to speed-up their infrustructure & QMS improvement, expand in R&D and perform clinical trials for their durgs to compete in the international market after 2016. Bangladesh got special benefit until 2016 by WTO in manufacturing and exporting drugs due to be an LCD country.
Amreteck Pharma USA helps multiple companies in Bangladesh to move beyond year 2016 in manufacturing, GxP and compliance requirements. Click the link below or visit us at www.amreteckpharma.com to find how your company can be benefited from our experience with USFDA and being at USA Pharmaceutical companies. We speak your language!
We provide following services:
1. Review and Implement USFDA approved Plant
2. Develop/Upgrade Quality Management Systems
3. Perform IQ/OQ/PQ, Cleaning Validation, Process Validation, Computer Validation, Utilities & facilities Qualification
4. Provide professional development training to improve employees work at your company
5. Provide GMP Training
6. Make your plant ready for Regulatory Inspections (i.e. MHRA, USFDA, ANVIS, Health Canada, JP, WHO, etc)
7. Provide recommendation and set-up your clinical trials requirements
8. Provide recommendation on process improvement and adopt risk-based aproach on your drugs quality
9. Provide Internal & External Audit services
10. Support in DMF file preparation and registration for USFDA and South America countries
Please contact us for your service needs at mchowdhury@amreteckpharma.com or call us at (307) 213-9878. We look forward to hear from you.
Mr. M. M. Chowdhury, ChE, Engineering, Validation, Quality, Audits & GMP Expert
Founder& CEO: Amreteck® Pharma LLC, USA
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