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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 involving 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.
For further detail contact,
Mahendra Joshi
Email: dossier@icpc.biz
Phone: +91-79-26870952
FAX: +91-79-40032655
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