Regulatory Consulting Services for Pharmaceutical Submissions

ClinChoice offers comprehensive regulatory consulting services related to pharmaceutical registration and submission, aimed at assisting pharmaceutical companies in smoothly navigating the entire process from drug development to market launch, ensuring compliance with the requirements of regulatory authorities worldwide.

Main consulting services

  • Development or Optimization of Registration Submission Strategies
    • Regulatory Environment Analysis: Evaluate regulatory requirements and the latest policies in the target market, identifying potential regulatory obstacles and opportunities.
    • Feasibility Analysis and Risk Management: Assess the risks of submission based on the product’s formulation development, pharmacological, and toxicological study plans, as well as preliminary data, providing strategies to mitigate submission risks.
    • Submission Strategy Planning: Considering the client’s product development plans and risk tolerance, coordinate with the clinical development plan and develop an overall submission strategy based on regulatory requirements, including communication strategies with regulatory authorities, timelines, key milestones, and resource allocation.
  • Document Preparation and Writing
    • Preparation of Submission Documents: Prepare submission documents that meet the requirements of regulatory authorities such as FDA, EMA, NMPA, PMDA, etc., including Pre-IND, IND, NDA, BLA, MAA, etc.
    • Technical Documentation Support: Provide writing or review support for technical documents related to Chemistry, Manufacturing, and Controls (CMC), non-clinical and clinical research.
    • Electronic Submission: Prepare and submit electronic submission documents that comply with eCTD (Electronic Common Technical Document) format or other electronic submission formats.
  • Clinical Trial Submission
    • Clinical Trial Protocol Design: Design scientifically sound clinical trial protocols to ensure the reliability and acceptability of trial data.
    • Clinical Trial Application (CTA): Prepare and submit CTA documents for global clinical trials.
    • Trial Management and Monitoring: Provide project management and monitoring services for clinical trials, ensuring compliance with Good Clinical Practice (GCP) standards.
  • Marketing Authorization Application
    • Formulating Marketing Authorization Strategies and Plans: Develop marketing authorization strategies and plans based on the product and indication, considering pre-marketing communication with regulatory authorities, the feasibility of rolling submissions, and the feasibility of priority review applications.
    • Marketing Authorization Application (NDA/BLA): Submit marketing authorization documents; prepare documents and samples required for registration inspection and site visits (if applicable), and coordinate and support registration inspections and site visits.
  • Submission Process Management
    • Execution of Submission Plans: Implement submission plans based on the submission strategy, ensuring timely submission.
    • Communication with Regulatory Authorities: Act as the client’s representative in communication with regulatory authorities, handling queries and requirements to ensure a smooth review process.
    • Review Tracking: Track the review process, provide progress reports, and respond promptly to feedback from regulatory authorities.
  • Support During Clinical Trials and Post-Marketing
    • Pharmacovigilance: Monitor and report adverse drug reactions post-marketing, ensuring the continued safety and efficacy of the drug.
    • Regulatory Updates and Maintenance: Track and interpret regulatory changes to ensure continued compliance of the product with the latest regulatory requirements.
    • Lifecycle Management: Provide regulatory support throughout the product lifecycle, including change applications, annual reports, and re-registrations.

ClinChoice’s Advantages

  • Professional Team: A multidisciplinary team with extensive experience in Chinese, American, European, and Japanese pharmaceutical regulations, providing high-quality regulatory consulting services.
  • Customized Solutions: Tailored registration submission strategies and solutions based on the specific needs of the client and the regulatory requirements of the target market.
  • Global Network: A broad network of international partners and branches, offering regulatory support and services worldwide.
  • Efficient Service: Rapid response to client needs, ensuring efficient progress of regulatory submissions, saving time and costs.
  • Quality Assurance: A strict quality control system ensuring the accuracy and compliance of submission documents, enhancing the success rate of submissions.