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REGULATORY AFFAIRS

We at Virchow Healthcare have built our regulatory team from the ground up comprised of efficient, hardworking, competent professionals with an extensive experience of pharma and medical device regulatory requirements among them.

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Our regulatory team is equipped to work in synergy with both the marketing and manufacturing teams. This includes processes beginning right from the nascent stages of product selection, compiling the required CTDs, ACTDs, eCTDs, through the life-cycle of product launch, and even during various post-launch activities.

Through their tireless efforts we have obtained approvals of ISO 13485, Colombia, Philippines, Kenya, Uganda, Kyrgyzstan, and Sri Lanka to name a few, as well as having CE approvals for various medical device products.

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Our clinical development team is also equipped to prepare protocols and tie up with leading hospitals and trial centers to successfully execute and manage various forms of clinical trials and studies.

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Today’s regulatory landscape is ever changing and staying up-to-date is always a challenge for any company. Our regulatory team’s ability to always stay abreast of the current and even upcoming trends gives Virchow Healthcare the needed edge.

  • WHO GMP

  • ISO 13485

  • US FDA 510(k)

  • INVIMA Colombia

  • FDA Philippines

  • NCE Kazakhstan

  • SBDMA Yemen

  • NMRA Sri Lanka

  • DDA Nepal

  • PPB Kenya

  • NDA Uganda

  • DPML Ivory Coast

  • NAFDAC Nigeria

  • TFDA Tanzania

  • FDA Ghana

Accreditations
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