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Regulatory Affairs

​Overview

 

Our Regulatory Affairs Consulting Services provide comprehensive support to pharmaceutical, biotechnology,

and medical device companies in navigating complex regulatory landscapes and achieving successful product

approvals globally.

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Regulatory Strategy Development​

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  • Development of global regulatory strategies for new products.

 

  • Identification of regulatory pathways for expedited approvals.

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  • Strategic advice for lifecycle management of approved products.

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Submission Preparation Management

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  • Preparation and submission of regulatory dossiers (e.g., IND, NDA, ANDA, BLA, MAA).

 

  • Coordination with regulatory agencies, including FDA, EMA, MHRA, and others.

 

  • Management of electronic submissions (eCTD) and ensuring compliance with submission standards.

 

  • ANDA Parking 

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Regulatory Intelligence

 

  • Monitoring and interpretation of changing regulatory requirements.

 

  • Impact analysis of new guidelines and regulations on existing portfolios.

 

  • Proactive advice to ensure compliance with evolving regulatory expectations.

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Labeling and Advertising Compliance

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  • Development and review of product labeling to ensure regulatory compliance.

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  • Assessment of promotional materials for adherence to regulatory standards.

 

  • Guidance on risk mitigation for off-label communications.

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