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Regulatory Affairs (RA) is one of profession in pharmaceutical industry with great potential and opportunities. We have two sub divisions of our Regulatory Affairs Department i.e. DOMESTIC and INTERNATIONAL.
In Hiranis Pharmaceutical regulatory department performs the following operations:
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- Collecting data , analyzing, preparing and presenting documents for registration to DRAP in Pakistan and Regulatory agencies of exporting countries and perform all subsequent dialogue to gain and maintain marketing authorization (MA) for the Pharmaceutical products or health care product.
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To Ensure that company comply with all of the regulations and laws according to GMP/cGMP and Drug Law.
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To Handle the matters with CDL and DTL laboratories in order to response of their queries/requirements
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To suggest the company regarding regulatory affairs climate that would affect proposed activities. describing the "regulatory climate" around issues like the promotion of prescription drugs compliance.
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Preparation of dossiers for exporting countries as per CTD/ACTD format or respective guidelines.
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GMP/Free Sale Certification and enforcement actions.
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Maintenance and Update of Product Master Files.
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Internal Compliance of Documentation.
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Coordination with all technical operation departments and marketing department.
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Intellectual Property Rights(Trademark).
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Business Development activities.
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Packaging development (artwork).
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