Regulatory Strategy Consulting Services

Our Services

• Stay Informed on International Regulations Across 100+ Countries or Regions: Our team continuously monitors regulatory updates in over 100 countries or regions, ensuring that our clients receive the most current and relevant information and helping our clients maintain compliance and avoid costly delays.
• Conduct Regulatory Feasibility Analysis: We assesses the viability of a product's regulatory pathway and provide a clear picture of what to expect, by evaluating the potential challenges and opportunities in different markets.
• Interpret Regulations and Guidelines: Regulations and guidelines can often be complex and ambiguous. Our experts decode these regulatory texts, offering clear and actionable interpretations.
• Develop Effective Submission Strategies: We provide tailored submission strategies that optimize the chances of approval. In this respect, our experts guide clients through the preparation and submission of dossiers, making sure all documentation meets regulatory standards and is presented in the most favorable manner.
• Offer Advisory Support and Interaction with Regulatory Authorities: Engaging with health authorities is a critical component of the regulatory process. Our consulting services include support for meetings and discussions with agencies such as the FDA, EMA, and others, and help our clients prepare for and navigate these interactions, ensuring effective communication.
• Provide Regulatory Guidance for Product Life Cycle Planning: We provide comprehensive regulatory information and support across the entire lifecycle, including the post-marketing surveillance, renewals, and updates.
• Others: We also provide legal status switches consulting services (such as Rx to OTC switches), product filing and variation strategies, advisory on CMC data generation for successful filing, query responses strategies, etc.