- Serve as FDA consultant, speaker and regulatory mentor/coach in FDA-regulated industry.- IR (pitch) deck preparation, mentoring/consulting for startups and manufacturers in biotech, pharma and medical device industry.- FDA expert consultant for 510k, PMA, biologics, drugs, cosmetics, combination products, and food.- FDA speaker for CGMP, QSR, QS, risk management, complaint, design control, drugs, biologics.. - Regulatory expert consultant to CEOs, senior management, venture capitals, financial firms.- Corporate compliance training for 21 CFR 820, CGMP, GLP, GCP, CAPA, complaint, and MDR- Consulting for regulatory submission for 510ks, PMAs, Pre-submission, IDE, HDE, CE mark, foreign registrations (MFDS, Health Canada, EU, TGA, ANVISA, CFDA, TFDA, etc.) - Issue regulatory opinions for audit, regulatory compliance and FDA inspection- Provide direction and guidance for FDA regulatory compliance to drug and medical device manufacturers - Provide guidance and direction on study design, verification and/or validation requirements, and final (test) reports (performance and clinical studies including biocompatibility, sterility, human factor testing, and risk management, etc.)- Frequently consult on the phone with fee (510k, PMA, CGMP, GLP, GCP, FDA inspection, 483s, MDR, CE marking, drugs, FDA advisory meetings).

At FDAnews, Inspection Insider provides the latest, best quality of key news on FDA inspection matters.- http://inspections.fdanews.com/- http://inspections.fdanews.com/experts

- FDA Regulatory, Quality and Compliance Matters- Medical Device Regulatory Process- Drug Regulatory Process- Packaging and Labeling- Medical Product Development- FDA Enforcement Matters

- Presents on FDA 510(k)s and PMA; EU medical devices (MDD, Directive 93/42/EEC); EU in vitro diagnostic medical devices (IVDD, Directive 98/79/EC); EU active implantable medical devices (AIMDD, Directive 90/385/EEC)- FDA GLP, GCP and cGMP- FDA 21 CFR Part 820: QSRs- Adverse event reporting (vigilance/surveillance system) in EU, Canada and US (MDR)- Global medical device regulations (US, EU, Canada, Argentina, Australia, Brazil, India, Japan, Mexico, Russia, South Korea, and Taiwan, etc.)§§TESTIMONIALS§§❶ “Dr. Lim is very knowledgeable. The amount of interaction between the participant and presenter was ideal. I would like to refer his trainings to my colleagues.” By QC/RA Mgr.❷ “Dr. Lim was great. The event was well organized and coordinated. I would recommend this to others.” By Attorney❸ “I enjoyed it very much.” By Dir. of RA/QA❹ “I think the material and instructor were very knowledgeable and material was excellent. The subject was well chosen and the design of presentation was most appropriate.” By QC/RA Mgr.❺ “My colleague referred me to this event and It was good value for the price. Excellent friendly presenter and coordinator. I would also like to recommend this seminar to others.” By RA Mrg.❻ “Dr. Lim was very knowledgeable and material was excellent. Example and templates of PMA & 510k submissions were very useful because it set the framework of how to submit a quality 510k.” By RA Mgr.❼ “I had very focused reason to attend this seminar: learning more about 510k, classes and requirements. The program was well organized and coordinated.” By QA Analyst❽ “All the topics were well chosen and the design of the presentation was most appropriate. I like the topic “Template for Submission” most. Dr. Lim is an excellent friendly presenter. Overall it was good value for the price.” By Managing Dir.❾ “Thanks for organizing it very well and professionally. I would like to attend next seminar.” By Mfg. Engr.

International Journal of Vaccines and Immunization (IJVI). IJVI is an Open Access, peer-reviewed, online journal dedicated to clinical and medical aspects of vaccines. IJVI highlights the importance of discoveries in vaccine research and immunization, such as the development and evaluation of vaccines, human and animal immune responses to vaccines, quantitative assays of vaccine efficacy, and clinical trials.

- Presentation to Biotech, Pharmaceuticals, and Medical Device Industry regarding GMP Regulatory Compliance Matters.- Medical Device, IVDs, Drugs, and Biosimilars- FDA 510(k) and PMA- FDA Compliance in Label, Labeling, Publication and Social Media- FDA 510(k) for IVDs- FDA GCP- FDA GLP and OECD GLP- Medical Device Adverse Event Reporting- FDA Medical Device Report (MDR)- FDA Recalls, Corrections and Removals- FDA BIMO Inspection- Medical Device Development and Approval Process- Medical Device Electronic Submissions- FDA Labeling- Registration and Listing- Reimbursement- Drug Development and Approval Process- Pharmacovigilance- eCTD

- FDA premarket notification 510(k)- Medical device complaint handling systems- Quality system regulations (QSRs)- Medical device regulations- FDA enforcement, quality and regulatory matters

- FDA premarket notification 510(k)- Medical device complaint handling systems- Quality system regulations (QSRs)- Medical device regulations- Medical device reporting- Recalls- Corrections and removals

- FDA Biosimilars- FDA 510(k) - FDA Compliance in Label, Labeling, Publication and Social Media- FDA 510(k) for IVDs- FDA GCP- FDA GLP- Medical Device Adverse Event Reporting- FDA Medical Device Reporting (MDR)- FDA Recalls, Corrections and Removals- FDA BIMO Inspection

- Provide regulatory counseling when needed.

July 22, 2015- Agency Interaction- Premarket Notification: 510(k)- Investigational Device Exemption (IDE)July 29, 2015- Premarket Approval (PMA)- Humanitarian Device Exemption (HDE)- Promotion and Advertising

- FDA 510(k)s for general medical devices- FDA 510(k)s for in vitro diagnostic medical devices ( IVDs)- Medical device complaint handling system- Global adverse event reporting- FDA medical device reporting (MDR)

**Webcast presentation to the professionals preparing for the US Regulatory Affairs Certification (US RAC)**- On July 23, 2014US FDA/agency interactionQuality system regulations (QSR; cGMP for medical devices)- On July 30, 2014Quality system regulations (QSR; cGMP for medical devices)Medical device promotion and advertising.- On August 6, 2014IND Requirements and SubmissionsSpecial Protocol Assessments IND MaintenanceNDA Requirements and SubmissionsPDUFA Fees and Approvals505(b)(2) NDAs- August 13, 2014Overview of Over-the-Counter Drug ProductsOrphan Drug DesignationsPREA RequirementsGMPs

- Medical device regulations - cGMPs- Medical device quality system regulations (QSRs)- Advised the program to provide better quality of practical and actionable contents.- Advised the Associate Dean to implement best practices to greatly improve contents and faculty practices/services.

- LIVE online presentation for professionals preparing to sit for Regulatory Affairs Certified (RAC) exam for medicines and pharmaceuticals in EU

- Strategic leadership- Global regulatory plan and strategy- Help share business operations- Help draft, revise and submit medical device research proposal(s)

- As one of three authors, we worked on EU medical device regulations (online class).- Medical Device History in EU- Regulatory Scheme in EU- Medical Device Directive (MDD)- Regulatory Requirements- Essential Requirements- Conformity Assessment- Declaration of Conformity (DOC)- Clinical Evaluation- Language and Labeling- Use of Symbols- MEDDEV Guidance Documents- Definition- Medical Device Classification- New Approach Directive- Active Implantable Medical Device Directive (AIMDD)- In Vitro Diagnostic Medical Device Directive (IVDD)- Adoption to National Law- Overview of CE Marking- How to Obtain CE Mark- Notified Bodies- Authorized Representatives- Competent Authority- Standards, Quality Assurance and Risk Management - Postmarket Requirements: Surveillance/Vigilance- Field Safety Notice (FSN)- Field Safety Corrective Action (FSCN)- Other Directives- Personal Protective Equipment (PPE) (89/686/EEC)- General Product Safety Directive (GPSD, 2001/95/EC)- Product Liability Directive (85/374/EEC)- Product Warranty Directive (1999/44/EC)- Waste Electrical and Electronic Equipment (WEEE) Directive (2002/96/EC)- Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment (RoHS) Directive (2002/95/EC)- Packaging and Packaging Waste Directive (94/62/EC)

- Oversee global scientific and regulatory matters.- Provide hands on direction and leadership.- Develop possible options and provide strategic and sustainable strategy. - Develop intellectual property portfolio and oversee patenting process (licensed to practice in patent cases before the USPTO).

- Provide regulatory strategy and intelligence service. - Draft and/or submit pre-market [510(k)] notification including pre-IDEs to FDA.- Provide consultation to cross-functional departments.- Interact with regulatory agency reviewers.- Provide expert advice on regulatory compliance and quality issues to cross-functional teams.***My Achievements***My recent achievements include, but not limited to, prompt and effective clearance of a medical device for herpes simplex virus detection and typing from FDA. Please see the links below. Letter of clearance:http://www.accessdata.fda.gov/cdrh_docs/pdf11/K111527.pdf FDA decision summary:http://www.accessdata.fda.gov/cdrh_docs/reviews/K111527.pdf

- Handled regulatory matters for left ventricular assist device (LVAD) (e.g., global labeling, labels, IDE, and PMA)- Identified areas for improvement in quality, risk management and regulatory matters (e.g., 21 CFR 820, ISO 13485:2003; ISO 14971:2007; 90/385/EEC; CMDCAS: Canadian Medical Device Conformity Assessment System)- Provided consultation on pre-clinical and clinical matters- etc.

I worked at the Office of the Center Director, Center for Devices and Radiological Health at FDA.-Reviewed regulatory applications (510ks, PMA and IDEs), which have been cleared and approved by FDA-Analyzed to identify potential health risk signals

-Reviewed/guided patentable subject matter for world-wide IP protection-Drafted and prosecuted patent applications including those involved in clinical trials -Guided and counseled invention-related subject matter-Certified for US regulatory affairs

-Launched and directed the human aging and cancer research program-Discovered for the first time that a component of Niacin extends the life span of human cells-Expert in viral gene delivery systems-Consulted intellectual property and regulatory issues

-Led a group of 12 people to uncover the molecular mechanisms of action for a small peptide/protein molecule in animal models and human cells-Directed testing of a peptide molecule and other drugs in both animal models and human cell models for bioavailability and toxicity

- Contributed to elucidating the molecular mechanisms of aging, anti-aging and tumorigenesis (cancer).- Worked on developing biological and analytical tools and methods for understanding the molecular mechanisms of various biological phenomena.

Aging Research at Chronogen

Human Genome Research Laboratory

- Contributed to elucidating the molecular mechanisms of tumorigenesis at the cellular and molecular levels.