Tech Repartee Consulting Pvt Ltd

Tech repartee is a Pharma regulatory and medical writing consultancy with core focus on providing regulatory, technical and medical writing services to Pharmaceutical industry and R&D laboratories involved in translational research.Repartee means quick responder and this is what we believe in, providing expert solutions in the shortest possible time. Team Tech repartee is a group international experts from Pharma Regulatory, Biomedical scientists, Medical writing experts, IPR experts and liaisoning agents. We at Tech Repartee like to take up challenges and confident of our expertise. The company has its headquarter at Gurgaon, India.
We emphasize on the translational research because it is at this stage that you need to address regulatory challenges, with our turnkey solution we not only improve your product/process but also save time & money. If you are facing challenges with regulatory agencies, our Regulatory affairs team can help you with, US FDA, CDSCO-India, EMEA, TGA-Australia, HSA-Singapore, MHRA-UK & ROW countries. We also have a competent team of Medical writers who can handle almost every therapeutic areas.
Our Services
Preparation & compilation of regulatory submission for Pharmaceutical formulations, API/ Excipients/ cell therapy/ biological products and Packaging materials in EU/US/ASEAN/African Countries/Semi regulated countries/ non Regulated countries.
Preparation & compilation of regulatory submissions, including Product Dossiers in ICH CTD format Module 1-5, for submission to the Regulatory Agencies
Preparation & compilation of regulatory submissions in electronic format for submission to EDQM
Preparation & compilation of COS / ANDA/ASMF/eDMF
Preparation & compilation of US DMF Type (For Dosage Forms, API and Intermediates,
Preparation & compilation US DMF Type IV (For Packaging materials)
resolving the queries as requested by the Customers and Regulatory Agencies
Impeccable record with CDSCO

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Privately Held

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