CEO

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Dr. David Lim, Ph.D., is an esteemed FDA Regulatory Consultant with over two decades of expertise in pharmaceuticals, medical devices, in vitro diagnostics (IVDs), and biotechnology. His exceptional academic background includes advanced training at prestigious institutions such as Duke University Medical Center, Caltech, UC Berkeley, and Lawrence Berkeley and Livermore National Laboratories. Dr. Lim has also made substantial contributions at the U.S. FDA, where he served as a Fellow Consultant, providing critical insights into regulatory pathways and ensuring patient safety across a wide range of therapeutic areas and device categories.

Renowned for his deep understanding of FDA regulatory requirements, Dr. Lim has completed over 300 FDA consulting projects involving submissions such as 510(k), PMA, De Novo, IDE, NDA, ANDA, BLA, IND, and Q submissions. His expertise has been instrumental in guiding numerous organizations through intricate regulatory pathways, achieving successful market clearances and approvals. As a consultant, he has led the development and review of regulatory filings, clinical trial designs, and post-market compliance strategies.

Dr. Lim is also a committed educator, mentor, and public speaker in the regulatory affairs field, sharing his knowledge and expertise to shape the next generation of regulatory professionals. His distinguished career exemplifies a dedication to advancing regulatory science and ensuring the safety, quality, and efficacy of medical products for global markets.

For over 20 years, Dr. Lim has provided expert consulting services and training across various regulatory areas, including FDA regulations and compliance in food, drugs, medical devices/IVDs, and biosimilars/biologics. His comprehensive experience spans all aspects of regulatory strategy, quality systems, and compliance, making him a trusted partner for organizations navigating complex regulatory landscapes.

Our FDA Regulatory Strategy Consulting provides comprehensive guidance to medical device, biologic, and pharmaceutical companies navigating the complex regulatory landscape of the U.S. Food and Drug Administration (FDA). This consulting focuses on ensuring efficient product development, regulatory submission, and market access while maximizing opportunities for expedited review and approval through specialized FDA designations. Key components include:

1. Regulatory Pathway Analysis and Planning

• Strategic Development: Identifying optimal regulatory pathways tailored to the product type (e.g., 510(k), PMA, NDA, BLA) and therapeutic target.
• FDA Engagement: Preparing for and facilitating Pre-Submission (Pre-Sub) meetings to align early-stage development with FDA expectations.
• Gap Analysis: Reviewing existing data, protocols, and processes to ensure compliance with FDA requirements and address potential deficiencies proactively.

2. FDA Designations for Expedited Review

• Breakthrough Therapy Designation: Providing guidance on meeting the criteria for therapies showing substantial improvement over existing options, including preparing and submitting robust designation requests.
• Orphan Drug Designation: Assisting with submissions for therapies targeting rare diseases, leveraging incentives like tax credits, fee waivers, and market exclusivity.
• Fast Track Designation: Supporting applications for therapies addressing serious conditions with unmet medical needs, including accelerated communication with the FDA.
• Accelerated Approval Designation: Guiding the development of surrogate or intermediate clinical endpoints to enable earlier approval for therapies addressing serious or life-threatening conditions.

3. Clinical and Regulatory Strategy Development

• Clinical Trial Design: Advising on study design, endpoints, and methodologies to meet regulatory expectations while optimizing time and cost.
• Data Strategy: Ensuring clinical and nonclinical data align with regulatory submission requirements and FDA standards for safety and efficacy.
• Labeling and Indication Development: Crafting product labels and indications that reflect approval criteria and target market needs.

4. Submission and Review Management

• Regulatory Submissions: Preparing and managing regulatory submissions, including 510(k), PMA, IDE, NDA, ANDA, BLA, IND, and associated supplements and amendments.
• Interactive Reviews: Facilitating ongoing communication with the FDA during the review process to address questions and concerns effectively.
• Regulatory Compliance: Ensuring post-approval activities meet regulatory requirements, including adverse event reporting and post-marketing studies.

5. Risk Assessment and Mitigation

• Regulatory Risk Analysis: Identifying potential regulatory risks and developing mitigation strategies to address them proactively.
• Contingency Planning: Preparing for unexpected delays or issues during FDA review.

6. Training and Organizational Support

• FDA Training: Educating internal teams on FDA regulations, submission processes, and best practices for engaging with the FDA.
• Regulatory Intelligence: Providing insights on regulatory trends, policy changes, and precedent-setting approvals to inform strategic decision-making.

Our Business Strategy and Optimization Consulting focuses on helping organizations identify, develop, and execute strategic initiatives to enhance overall business performance, achieve competitive advantages, and align operations with long-term objectives. This form of consulting leverages data-driven analysis, industry insights, and innovative approaches to optimize resources, streamline processes, and drive growth. 

Good Laboratory Practice (GLP) Consulting

GLP consulting focuses on ensuring that preclinical laboratory studies adhere to rigorous standards for quality and integrity, which are critical for regulatory submissions.

• GLP Compliance Assessments: Conducting gap analyses to evaluate laboratory operations, documentation, and adherence to GLP regulations.
• Study Protocol Development: Guiding the design of nonclinical studies, including toxicology, pharmacokinetics, and pharmacology, to ensure GLP compliance.
• Data Integrity and Reporting: Implementing robust systems to ensure accurate and reproducible data collection, analysis, and reporting.
• GLP Training: Educating laboratory staff on GLP requirements, including roles and responsibilities, documentation, and study conduct.
• Facility and Process Audits: Reviewing laboratory infrastructure, equipment validation, and procedural controls to ensure alignment with GLP standards.

Good Manufacturing Practice (GMP) Consulting

GMP consulting ensures that manufacturing processes for drugs, biologics, and medical devices meet the stringent quality standards required for regulatory compliance and product safety.

• GMP System Design and Implementation: Developing and optimizing Quality Management Systems (QMS) to meet 21 CFR Parts 210/211, 21 CFR Part 820, or ISO 13485 requirements.
• Facility Design and Qualification: Advising on facility layout, equipment qualification (IQ/OQ/PQ), and utilities validation.
• Process Validation: Assisting in process development, qualification, and ongoing validation to ensure consistent product quality.
• Supplier and Vendor Audits: Evaluating and qualifying suppliers to maintain compliance across the supply chain.
• GMP Training: Providing tailored training on GMP principles, including documentation practices, deviation management, and CAPA (Corrective and Preventive Actions).
• Regulatory Inspection Preparation: Preparing companies for FDA, EMA, and other regulatory inspections, including mock audits and response strategies for 483 observations and warning letters.

Good Clinical Practice (GCP) Consulting

GCP consulting supports clinical trials by ensuring compliance with ethical and scientific standards for conducting, recording, and reporting clinical studies.

• Clinical Trial Design and Protocol Development: Assisting in the creation of robust trial designs and protocols that comply with GCP guidelines and regulatory expectations.
• Investigator and Site Training: Training investigators and site staff on GCP principles, including informed consent, patient safety, and data collection.
• Monitoring and Auditing: Conducting on-site or remote monitoring to ensure adherence to the study protocol and regulatory requirements.
• Data Integrity and Management: Implementing systems for accurate data collection, analysis, and reporting to ensure reliability in regulatory submissions.
• Regulatory Submissions: Supporting the preparation and submission of INDs, BLAs, NDAs, and other regulatory documents.
• Inspection Readiness: Preparing sponsors, investigators, and sites for regulatory inspections, including mock inspections and audit response strategies.