For Global Markets
Documentation control is an integral part of LODAAT's process. All documents being generated are highly controlled and archived according to international standards. Well defined process controls and documentation procedures are the key to achieving quality documentation and ensuring qualitative output. We strive to meet all pre-determined specifications consistently.
We possess a well defined regulatory affairs structure managed by highly qualified & experienced experts in this field. We have the capability to develop and file CTD DMF, US DMFs, COS and other registrations required in various markets.
LODAAT’s priority always has been the quality of its products, an integral part of this is the Technical Documentation and support that we provide to our global partners.
LODAAT has invested earnestly in this sphere and we have a full fledged team of Regulatory Experts preparing Dossiers conforming to national and international regulations in various formats including Dossiers in CTD/ACTD formats.
We have requisite infrastructure & expertise to ensure proper regulatory approvals of our clients and on-site pre-approval inspections by competent agencies like US FDA, MHRA, EDQM etc.
Through our partners, we have more than 25 ACTD / CTD Dossiers and by end of 2013 we will have successfully completed and submitted 50 CTD / ACTD Dossiers. Besides for ROW markets we have a basket of more than 360 Dossiers.
The implementation of corrective and preventive actions concluded from an investigation, are closely monitored by the quality assurance team. LODAAT has a well established system for handling customer complaints. This is illustrated via a step by step procedure, right from log in of customer complaints till its resolution.
One of the salient features of our quality systems is a comprehensive strategic planning and management review process. The strategic plan includes an emphasis on quality management systems, periodic review of quality systems and review of the progress towards achieving quality objectives.
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