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Global regulatory consulting solutions

Streamline your regulatory interactions to expedite development
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Navigating the regulatory landscape and staying up to date with the latest changes is a complex process that requires extensive insight into the guidelines. Leveraging regulatory consulting solutions can help you achieve an efficient development pathway that meets stringent regulatory requirements, while optimizing timelines and resources.

Regulatory solutions across your development journey

Regulatory Scientific Review, Gap Analysis

  • Detailed review of nonclinical data packages
  • Gap assessment and recommendations
  • General nonclinical consultancy
  • Regulatory foresight and risk mitigation

FDA Special Protocol Assessment (SPA) Support for Carcinogenicity Study Protocols

  • Preparation and finalization of SPA submission document
  • Regulatory project management and tracking
  • Interactions with FDA during review process
  • Carcinogenicity waiver requests and overall carcinogenicity strategies

Regulatory Meeting Support Services

  • US FDA Pre-Investigational New Drug
  • US FDA INTERACT
  • UK MHRA scientific advice
  • EU EMA scientific advice
  • Other regional regulatory authorities upon request

Regulatory Writing Services

  • Writing support for Marketing Authorization Applications (MAA), e.g. Sections 2.4 and 2.6
  • Investigator Brochure writing and editing
  • Preparation of early Target Product Profiles (TPP)  and associated strategic advice
  • Pediatric development strategies and pediatric investigation plans (PIP)
生理化学に関するエンドポイントのほとんどは農作物や化学品の有効成分の標準となっていますが、その評価にあたって適切な試験方法を選択することが極めて重要です。このブログでは、標準的なエンドポイントのいくつかとその評価試験に注目し、扱いの難しい物質における規制要件の変化や改正された試験方法と照らし合わせながら検証していきます。

Your pathway to regulatory success

  • Specialized Knowledge: In-depth expertise in laws and regulatory processes.
  • Time and Resource Efficiency: Global team with extensive experience optimizing resources.
  • Risk Management: Strategies to identify and mitigate regulatory risks.
  • Market Entry Optimization: Stratergy submissions and interactions for market success.
  • Customized Solutions: Tailored regulatory advice and support across phases.

Try program integration to maximize the value of your asset

医薬品開発にプログラム型のアプローチを取り入れることで、時間を節約して効率を高めます。 With a team of scientific, regulatory and certified program management advisors and prospective planning, you can advance through the long and complex scientific and regulatory process to make smarter decisions.

詳細
Try program integration to maximize the value of your asset

Your trusted global laboratory science partner – from discovery to market

Leverage world-class decision data, insights and technology to develop your next breakthrough, while gaining scale, speed and efficiency through our global network capabilities. Advance confidently with our experts in science; from discovery to market, we provide an end-to-end portfolio of lab testing and study solutions including Discovery, Toxicology, Pharmacology, Metabolism, Bioanalytical, Environmental and Support services.

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