Dossier writing is a skill and dossier reading is a Art …CPPL Team.Almost all pharmaceutical manufacturers are having their own regulatory affairs departments but it is not always necessary that regulatory professionals are having knowledge about process and also we observed that there is no strong coordination in QA and regulatory affairs department.
Dossier once written by Regulatory professional must be reviewed before submission to any authority . Small mistakes leads to a big loss or rejection of Dossier.
Example: In rush of document if by mistake wrong ingredient specification has been inserted by Regulatory professional in dossier you can not revert or recheck the same post submission. Another best example is audit of process documents like PDR shall match with manufacturing process, or specification shall match with unit formula etc etc. these are some examples of errors while writing dossiers.
In CPPL our technocrats takes care of review of dossier with their thorough knowledge of process and analytical documents and gives comments to your team for corrections.
Audit of Dossier is now a days necessary because if wrong dossier or inadequate dossier has been submitted it will lead to wastage of time and money, sometimes it may lead to rejection of dossier.To avoid this CPPL recommends audit of dossiers before submission so we can guide you at our best
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
Dossier Audit is necessary :
To avoid future queries
To save time and money
To understand and evaluate functioning of your regulatory team
To get perfection in Dossiers
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