Precision, Compliance, and Expertise in Pharmaceutical Chemistry
Chemist Consultants
Our Expert Consultants
Chemists
At xFDA Consultants, our team of chemists brings decades of experience in regulatory science, drug development, and pharmaceutical consulting. With expertise spanning organic chemistry, analytical methods, regulatory affairs, and drug formulation, our consultants provide the highest level of technical knowledge to support pharmaceutical companies in achieving compliance and success.
Meet Our Chemists
xFDA’s Chemists are experts in regulatory science and drug development, with extensive experience from both the FDA and the pharmaceutical industry. We help companies navigate complex chemistry, manufacturing, and controls (CMC) requirements, ensuring your products meet the highest standards for regulatory approval.
Expert in Organic Chemistry | Former FDA Chemistry Reviewer
Expertise: Organic Chemistry, Biochemistry, Microbiology, Drug Product Quality
FDA Experience: 19 years at the FDA, Chemistry Reviewer for Neuropharmacological Drug Products
Industry Experience: 14 years as Senior Scientist in the Pharmaceutical Industry
Dr. holds a PhD in organic chemistry with minors in biochemistry and microbiology. During his 19-year tenure at the FDA, he served as a chemistry reviewer for neuropharmacological drug products and chaired a task force for two FDA guidelines. As an ICH expert, he contributed to the development of global drug product quality standards.
Key Contributions:
Chaired FDA task forces on drug quality guidelines
Served as an ICH expert on pharmaceutical quality
Senior scientist with extensive industry experience in pharmaceutical chemistry
Expert in Phytochemistry | FDA Consultant for OTC and Topical Drug Products
Expertise: OTC Drug Products, Natural Products, Prescription Topical Products, CMC
FDA Experience: IND and NDA Chemistry Reviewer, Monograph Development
Dr. holds a PhD in phytochemistry and has extensive experience in over-the-counter (OTC) and natural drug products. At the FDA, he was responsible for reviewing IND and NDA submissions, drafting monographs for OTC products, and developing FDA standards and regulations for marketing OTC topical and natural drug products.
Key Contributions:
Developed FDA standards for OTC and topical drug products
Reviewed IND and NDA submissions for market approval
Expert in natural drug formulations and regulatory compliance
Expert in Medicinal Chemistry | CMC and Risk-Based Approach Specialist
Expertise: Inhalation & Pulmonary Drug Products, Oncology, Radiopharmaceuticals, Combination Drug Products
FDA Experience: 25 years at the FDA, QbD/PAT/QS Expert
Industry Experience: Consultant since 2007 for pharmaceutical companies
Dr. has 25 years of experience at the FDA and has served as a pharmaceutical consultant since 2007. His expertise spans inhalation and pulmonary drug products, oncology, radiopharmaceuticals, and combination drug products. He specializes in risk-based approaches, including Quality by Design (QbD) and Process Analytical Technology (PAT).
Key Contributions:
Extensive experience in FDA regulatory submissions for complex drug products
Expert in QbD and PAT methodologies for pharmaceutical manufacturing
Consultant for pharmaceutical companies in global regulatory compliance
Expert in Analytical Chemistry | FDA CMC Reviewer
Expertise: Small Molecules, Biologics, Drug Approval Processes
FDA Experience: 16 years at the FDA, Reviewer for New & Generic Drug Products
Industry Experience: Former Executive Director of CMC Regulatory Affairs in Pharma
Dr. holds a PhD in Analytical Chemistry and has 16 years of experience at the FDA overseeing the approval of new and generic drug products. He later held leadership roles in major pharmaceutical companies, where he managed scientific affairs and specifications development for drug formulations.
Key Contributions:
Led CMC regulatory affairs for a major pharmaceutical company
Reviewed specifications for pharmaceutical sciences and chemical development
Specialized in small molecule and biologic product approvals
Expert in Analytical & Organic Chemistry | FDA Reviewer and Industry Specialist
Expertise: Analytical Method Development, Biologics, Small Molecules
FDA Experience: 16 years at the FDA, NDA Reviewer
Industry Experience: 18 years in the pharmaceutical industry
Dr. has expertise in analytical and organic chemistry with an MS in both. He spent 16 years at the FDA as an NDA reviewer and 18 years in the pharmaceutical industry, where he developed analytical methods, set specifications, and created test methods for proposed drug products.
Key Contributions:
Developed analytical methods for FDA drug approvals
Extensive experience in biologics and small molecule drug development
Worked in both regulatory and industry environments
Regulatory Science Expert | FDA Reviewer & Pharmaceutical Consultant
Expertise: Regulatory Science, Preformulation, Generic & New Drug Products
FDA Experience: 8 years at the FDA, IND & NDA Application Reviewer
Industry Experience: 20+ years in research, regulatory science, and industry consulting
Dr. has over 20 years of experience in regulatory science and research, including 8 years at the FDA reviewing IND and NDA applications. She has extensive expertise in drug formulation, regulatory compliance, and pharmaceutical development.
Key Contributions:
Advised firms on IND and NDA submissions
Assisted pharmaceutical companies with regulatory compliance
Specialized in preformulating and generic drug product approvals
Why Our Chemists
Our chemists provide unparalleled expertise in regulatory compliance, drug formulation, and quality assurance. Their experience in both the FDA and the pharmaceutical industry allows them to offer comprehensive guidance tailored to your needs.
Key Advantages:
Extensive experience in regulatory review and compliance
Expertise across small molecules, biologics, and combination drug products
Proven track record in IND, NDA, and CMC regulatory affairs
Deep knowledge of FDA standards, guidelines, and industry best practices
Strong backgrounds in pharmaceutical research and product development
Don’t Wait to Get Started
Work with Our Chemists
Our expert chemists offer a wealth of experience to tackle your regulatory and scientific challenges. Whether you require chemistry, manufacturing and controls (CMC) expertise, analytical chemistry support, or drug formulation guidance, xFDA’s team is ready to assist.
Need specialized chemistry guidance? Contact us today to discuss your project needs with an xFDA chemist.