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Regulatory & Clinical Development Services

Pre-clinical/Non-clinical Studies Services

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NGG can provide a wide range of pre-clinical/non-clinical support:

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  • Pre-clinical Studies Strategic Planning

  • Pre-clinical Studies Gap Analysis

  • Pre-clinical Studies Protocol Review

  • Pre-clinical Studies Site Proposals Review and Support with Providers’ Discussion

  • Other Pre-clinical/Non-clinical Studies Support Based on Your Individual Needs

Clinical Studies Services

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  • Clinical Studies Strategic Planning in Close Coordination with Regulatory Strategy and Planning

  • Clinical Studies Gap Analysis

  • Clinical Studies Protocol Review

  • Clinical Studies Site Proposals Review and Support with Providers’ Discussion

  • Other Clinical Studies Support based on Your Individual Needs

Regulatory Services

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NGG offers a wide range of regulatory support from working together on your Investigator’s Brochure (IB) and Investigational Medicinal Product Dossier (IMPD), preparing for Scientific Advice Meetings (e.g., SAM, pre-IND, RMAT designation, ATMP Classification, etc.), Clinical Trial Applications (CTA) and IND, to compilation and filing of eCTDs and the related PharmacoVigilance aspects at each stage of your product development.

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  • Regulatory Strategy and Planning

  • Preparation of IMPD, IB, and other necessary documents to initiate clinical trials

  • Gap Analysis of the existing IMPD and IB

  • IND compilation and preparation

  • Clinical Trial Applications Packages

  • EMA/Local Agencies Scientific Advice Meetings and FDA Meetings Briefing Packages (pre-IND, EOP2, etc.) and assistance during and after the meetings

  • Applications for expedited and accelerated assessment (e.g., ATMP Classification, RMAT Designation, Orphan Drug Designation, etc.)

  • eCTD compilation and gap analysis

  • PharmacoVigilance

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