Quality Regulation Infrastructure for Pharmaceutical API Manufacturing from Enaltec Labs.

Quality & Regulatory

R & D Infrastructure and
Technical Capabilities

Why Us

Quality & Regulatory

Quality Systems form the backbone of the way we do business:

The requisite quality systems conforming to National and International regulations have been implemented across all our operations to ensure qualitative output at each step. We have requisite infrastructure and expertise to ensure proper regulatory approvals of our clients and on-site-pre approval inspections by competent agencies for US FDA, MHRA, EDQM etc.

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Some of the salient features of our quality systems are listed below:

Strategic planning and management review is implemented which includes emphasis on quality management systems, periodic review of quality systems and review of the progress towards achieving quality objectives.
Regulatory affairs: We possess a well defined regulatory affairs structure managed by highly qualified & experienced experts in this field. We have capability to develop and file CTD DMF, US DMFs, COS and other registrations required in various markets.
Documentation control: all documents being generated are properly controlled and archived according to the international standards for document control.
Handling of deviations, corrective and preventive actions: The implementation of corrective and preventive actions concluded from an investigation, are closely monitored by the quality assurance team.
Well established procedures for handling of customer complaints are in place at our end, which illustrates step by step procedure right from log in of customer complaints till resolving the complains.

Well defined process controls and documentation procedures are the key to achieving quality documentation and to ensure qualitative output meeting all the pre determined specifications consistently.

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