Drug Regulatory Solutions

Drug Regulatory Solutions

Vastrapur, Ahmedabad, Gujarat
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Company Factsheet

Nature of Business
Service Provider

Year of Establishment
2011

Annual Turnover
Upto Rs. 50 Lakh

Products & Services

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Pharmaceutical Analytical Method Validation Service

Ball Bearing
  • Analytical Method Validation Protocol and Report
  • AMV of Assay,Related Substances and Residual Solvents
  • Comparative Dissolution with similarity and disimilarity factors etc.
  • Chromatograms
  • Forced Degradation Study 
  • Freeze thaw study
...more
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Pharmaceuticals Dossier Services

Ball Bearing
  • Regional
  • ACTD (Part I,II, III, IV)
  • CTD (Module 1,2,3,4,5)
  • NeeS format
  • eCTD
...more
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Services For Pharmaceuticals

Ball Bearing
    • Writing Dossiers for Pharmaceutical Formulations, Preparation and compilation of Drug Master Files(DMF)
    • DRS is having Expertise in writing Dossiers in CTD, ACTD, eCTD Format
    • We have ready Database for Preparation of DMF AND DOSSIERS, CTD Files or ACTD Files
    • Resolving Regulatory Queries of DOSSIERS and DMF's or CTD
    • We can give experts opinion on the Guidelines for Drug Master File , DMF and Dossiers for submission to regulatories.
...more
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BA/BE Study for Capsules/Tablets

Ball Bearing
DRS has good relationship with various reputed CROs in the country and helps in getting below Services at competitive rate:
  • Bio Equivalence Study Report
  • Protocol
  • Clinical Report
  • Bio analytical Report
  • Clinical Trials
  • PSUR
  • Risk Management and Pharmacovigilence Service
...more
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Pharma DMF (Drug Master File)

Ball Bearing
  • Original Vendor DMF
  • CTD Format
  • BP or USP grade DMF
  • AMV with API chromatograms for Inhouse DMF
...more
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Method Validation Service

Pharmaceutical Analytical Method Validation Service
...more
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View All Services »

Reach Us

Gmap

Drug Regulatory Solutions P/2, Suhagan Complex, Near Management Enclave Vastrapur, Near Management Enclave, Vastrapur,
Ahmedabad-380015, Gujarat, India

Hiren Patel ( Business Development Manager )
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