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David Lim, Ph.D.

TCG Consultant

David Lim, Ph.D., is a seasoned FDA consultant with extensive expertise in regulatory affairs, quality systems, compliance, and product development within the pharmaceutical, biotechnology, and medical device industries. With a distinguished background in both academia and industry, Dr. Lim brings a wealth of knowledge and experience to assist clients in navigating the complex regulatory landscape of the Food and Drug Administration (FDA).


Dr. Lim's expertise encompasses a wide range of areas, including regulatory strategy development, pre-submission guidance, regulatory submission preparation and review, compliance assessments, quality system optimization, and remediation strategies. He works closely with clients to ensure that their products meet FDA regulations and requirements, guiding them through every step of the regulatory process from product development to market approval and post-market compliance.


Known for his meticulous attention to detail and commitment to excellence, Dr. Lim is dedicated to helping companies achieve regulatory success while maintaining the highest standards of quality and safety. His deep understanding of FDA regulations, combined with his strategic insight and practical approach, makes him a trusted advisor for companies seeking to bring their products to market efficiently and effectively.


Whether it's navigating the regulatory requirements for new product approvals, addressing compliance issues, or optimizing quality systems, Dr. Lim provides tailored solutions to meet the unique needs of each client. With his guidance, companies can navigate the regulatory landscape with confidence, ensuring compliance and accelerating the path to market success.

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Auditing & Assessments

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Auditing & Assessments

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Inspection Readiness

Regulatory Agency Response & Remediation

Auditing & Assessments

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Regulatory Agency Response & Remediation

Regulatory Agency Response & Remediation

Regulatory Agency Response & Remediation

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Specialized Services

Specialized Services

Regulatory Agency Response & Remediation

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Regulatory Support

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Education & Training

Specialized Services

Education & Training

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Thank you for your interest in Toscano Consulting Group (TCG). Do not hesitate contacting us for any of your consulting needs.

Toscano Consulting Group

Phone: (786) 201-3663 Email: operations@thetcg.org

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