Requirement of Clinicle Trials for Drug registration:

Generic pharmaceutical products need to confirm to the same standards of quality,efficacy and safety as required of the originator’s (innovator) product. Specifically,the Generic product should be therapeutically equivalent and interchangeable with the reference product.Testing the bioequivalence between a test product pharmaceutically equivalent or a pharmaceutical alternative and a suitable reference product in a pharmacokinetic study with a limited number of subjects is one way of demonstrating therapeutic equivalence. Generic drug applications are termed “abbreviated” because they are generally not required to include preclinical and clinical data to establish safety and effectiveness. This paper provides the information about important aspect involved in bioequivalence and Regulatory requirement for Bioequivalence study.

CPPL Team understands all requirements of Clinical and BA BE Study for different regulatory authorities hence is advising perfect solution in clinical sector also

Cyclone Pharmaceuticals Pvt Limited had audited and identified some CRO Centres which are having great expertise in this sector.Most advantageous point is CPPL team is having vigilance on the documents provided by service providers and it helps client for getting perfect documents.Document is reviewed and all the queries are being resolved from CRO and post submission queries will be minimised.

In your all kind of regulatory compilations,creation of documents and submission Cyclone Pharmaceuticals Pvt Ltd,the Pharmaceutical Consultants of India will help at every stage.Unlike other consultants we have team with QA,QC ,Production and Regulatory sector so review of documents ,compilation of dossiers and Query answering is ultimately easiest task for CPPL

Regulatory consultancy services of Cyclone Pharmaceuticals are proven services with highest Quality and Lowest cost.Our compiled documents many times are being accepted by regulatory authorities without single query. CPPL team is always alert for new updations in regulations provides perfect Drug Dossier,DMF,CTD,ACTD,KDMF,USDMF.eCTD,EUDMF,USDMF and other format compilation

    Comprehensive Bioequivalence Solutions
  • Protocol design and development
  • Phase I trial operation and management
  • Data management
  • Pharmacokinetic research
  • Bioanalysis
  • Statistical analysis,Report production
    Why to Choose CPPL as your Regulatory and Dossier Partner
  • Knowledge of Pharmaceutical Technologies
  • Knowledge about formulation and analytical techniques
  • Minimises time of registration with it's Perfect dossier service
  • Complete Support for Generating documents like PV,AMV,Stability
  • Comparativelly very Low Cost (Do not compaire with computor operators who provide Dossiers free of cost)
  • Honest servives ,we says yes if it is possible and no if having any difficulties
  • To serve Pharmaceutical Industry with best quality services and to bring a Quality culture in Documentation and regulatory services
  • Note : CPPL The best regulatory service providers of India do not compete with any other service providers because we know we are best