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Biomedical Consultants
Your choice for integrated scientific and regulatory advice for drug and drug/device development.
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Who we are.
Dr. Frances Mielach, Principal and Owner, has extensive U.S. and international drug development and drug safety experience in government, industry, and private consulting. Her areas of expertise include strategic regulatory, scientific, safety, due diligence, and legal aspects of drug and drug/device development, 505(b)(2) drug development, orphan drug development, and Small Business Innovation Research (SBIR) grant applications.
During her five year tenure as a Pharmacology/Toxicology reviewer and supervisor in the FDA’s Division of Antiviral Drug Products, Dr. Mielach helped create FDA's first formal Pre-IND program, was the CDER Center Expert in Immunotoxicology, worked on several committees that produced FDA and ICH guidances and policies, and received FDA recognition awards for her work and contributions to HIV and AIDS drug development and approval.
During 25 years since leaving the FDA, Dr. Mielach has been a private consultant to pharmaceutical and drug/device companies, venture capital firms, technology transfer companies, and law firms. She has been a scientific peer reviewer of SBIR grants and served as Vice President, Regulatory and Scientific Affairs at Myriad Pharmaceuticals.
Dr. Mielach earned her Ph.D. in Toxicology from the University of Medicine and Dentistry and Rutgers University Joint Graduate Program in Toxicology and is a Diplomate of the American Board of Toxicology. She earned her B.S. in Pharmacy from the University of Utah College of Pharmacy and is a Registered Pharmacist in Utah and California. Dr. Mielach is Principal and Owner of Wise Choice Wellness.
What we do.
- Provide strategic support that saves time and resources
- Provide expert answers and solutions to development problems and issues
- Facilitate proactive, productive interactions from pre-IND through post-NDA
- Mediate and resolve scientific and regulatory issues
- Prepare FDA and SBIR submissions to meet agency expectations
- Conduct detailed regulatory and nonclinical due diligence to identify assets and liabilities
- Prepare corporate and academic teams for due diligence
- Provide in-house training seminars and workshops
Why we're different.
- We help you get it right the first time.
- We tailor our services to fit the specific needs of your development program.
- We begin with the end in mind to help you implement a development plan that integrates all disciplines and supports the clinical program from start to finish.
- We help you avoid unnecessary costs and delays. In early development, this helps you achieve “bench to man” as soon as possible.
- We think win-win to help you work with FDA and other agencies proactively and productively.
- We’re networked with seasoned subject experts to help you solve unusual problems and issues.
- We help you understand how FDA and SBIR reviewers think and what they expect.
- We help create documents and presentations that stand up to peer review.
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