What We Do
Medeira Consulting provides strategic regulatory and drug development consulting to the pharmaceutical industry for drug and biologic development and FDA regulatory submissions.
Our experts include toxicologists, clinical pharmacologists, clinicians, chemists, and project managers, with an average of over 25 years of pharmaceutical industry and regulatory experience per individual.
We have in-depth experience in FDA regulations and requirements for drug development, drug manufacturing, and drug application submission as well as FDA drug review and approval processes.
We provide our expertise to clients in pharmaceutical industry for their drug development programs and FDA regulatory submissions including overall drug development strategies/plans for NME 505(b)(1) and 505(b)(2) applications, and biologics, communications with FDA from pre-IND meeting to IND filing, various clinical development stages after the IND opening, and NDA/BLA filing.
We communicate with the FDA on our client’s behalf to navigate drug applications through FDA’s regulatory review and approval processes (from Pre-IND, IND filing, various clinical development phases to NDA/BLA submissions). We have built a proven reputation for high quality, trust, and excellent track records through regulatory & drug development consulting and FDA submissions.
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What We’ve Done
We have worked on more than 60 IND projects from over 45 pharmaceutical companies, with more than 50 US FDA IND safe-to-proceeds to date (as of June 2020). We also continue to work with clients after the IND opening in various clinical development phases, including CMC manufacturing. Several drug candidates are currently in the Phase 2, Phase 3, and NDA submission stages.
The therapeutic areas of these IND projects cover all FDA clinical Therapeutic Review Divisions, demonstrating our broad and valuable scope of knowledge regarding all FDA Review Divisions.
About two-thirds of these IND cases are NME drugs, while the remainder are 505(b)(2) drug candidates.
We have worked on investigational drug products with various dosage forms for various routes of administration including Tablets, Capsules, Topical Gel/Spray, Buccal Film, and Sterile Injections as Liquid, Lyophilization Powder, Suspension, Emersion, Liposome, and Microsphere.
We have worked on biologic drug applications including peptides, pegylated peptides, proteins, and monoclonal antibodies.
More than 50 FDA-approved INDs that we have filed are currently in various clinical development phases. Several drug candidates have already entered the NDA stage as well.
Founding Partners
Partner
Derek Zhang, Ph.D.
Dr. Zhang has over 20 years of combined experience in drug development and regulatory review/approval, including 4 years of industrial experience at Pfizer, 6 years as a Senior Clinical Pharmacology Reviewer in the Office of Clinical Pharmacology at the Food and Drug Administration (FDA), and over 10 years of experience in independent drug development and regulatory consulting.
Dr. Zhang has in-depth experience in drug development plans/strategies, as well as regulatory review and approval requirements. Over the past 10 years, Derek has been providing regulatory and drug development consultation services to clients in the pharmaceutical industry for their new drug development programs, including 505(b)(1) and 505(b)(2) drugs and biologics, in the United States. His consulting scope covers but is not limited to the overall drug development strategies/plans and FDA IND filing preparation, FDA interactions from pre-IND meeting, IND filing, EOP2 meeting and pre-NDA meeting, and clinical development programs after the IND opening. Dr. Zhang has contributed to more than 60 IND projects, 50 US FDA IND approvals, and 2 NDA submissions to date, and continues to work with clients after the IND opening in various clinical development phases.
Dr. Zhang has authored or co-authored more than 40 papers, book chapters, posters, and invited presentations in areas of clinical pharmacology, including bioequivalence and risk assessment.
Partner
Zi-Qiang Gu, Ph.D.
Dr. Gu has over 29 years of working experiences in the field of pharmaceuticals, including over 14 years with the US FDA. He has extensive CMC and CGMP working experience concerning different phases of drug discovery, development and commercial manufacturing, as well as expertise with drug application preparation and review of IND, ANDA, NDA and post-approval change supplements.
Dr. Gu has been working as a pharmaceutical consultant for Chemistry, Manufacturing and Controls (CMC) as well as Current Good Manufacturing Practice (CGMP) for the pharmaceutical industry since 2011. He has been providing consulting for pharmaceutical companies in preparation for CMC in drug applications as well as to prepare for GMP inspections of API, OSD and sterile injection manufacturing facilities. Dr. Gu has successfully helped many companies pass US FDA GMP inspections and receive approvals of their drug applications from the US FDA.
Dr. Gu has authored/co-authored over 50 peer-reviewed scientific papers, patents, and abstracts, and is regularly invited to give presentations and lectures on CMC and GMP related subjects.