Our contact is as follows
HARI RAM GOEL
Address :HOUSE NO. 41, GURUNANAK NAGAR,
BALTANA,DISTT(MOHALI),PUNJAB.India pin. 140604
Telephone : + 91 -962-564-5858 | 701-893-8101
Email : firstname.lastname@example.org
Contact Pharmaceutical Dossiers
Pharmaceutical industry is regulated to a variable extent across the world. Regulatory agencies require Pharmaceutical Dossiers to gain approval to market drugs. The Pharmaceutical Dossier comprises of various documents representing years of research that includes multi-disciplinary information (including preclinical and clinical data) regarding the safety and efficacy of a drug.
Pharmaceutical Dossier Management Process
The regulatory process requiring Dossier Submissions vary from country to country and involves numerous interactions between the submitting company (sponsor) and the regulatory authority (agency).
The burden of compiling documentation and presenting it in a compliant format rests on the sponsor’s (company’s) shoulders. This process is very complex and involves considerable costs and requiring management of all the components during the approval process.
Our Dossier Management services
One of the biggest challenges of Dossier Submission is to collect exhaustive information on several compliant components which makes it quite frantic and sometimes chaotic process.
This is where we can help sponsors (companies) by our value added services. Our submission / dossier professionals generate this information from numerous sources including data management systems, medical writing departments, official pharmacopoeias, manufacturing sites etc. Once created, the documentation is compiled as dossier in standard formats like CTD, ACTD.
This is why companies look for ways to increase efficiency and cut time and costs in the dossiers submission process. We will be too glad to offer our services in this regard.
we have also a blog of our own where users can find very useful information regarding pharma regulatory and laws and rules for the good document and much more. this blog is specially created to provide the basic info about regulatory.Our team members manage this blog and make customers aware about current pharma market.
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