Welcome to Global Regulatory Toxicology Consulting. GRTC specializes in regulatory toxicology consulting worldwide, offering quality services to meet your specific needs
Belgo-american scientist with 25+ years of experience in the biopharmaceutical industry acquired mostly overseas, JF prides himself as a veteran of the biomolecules R&D. As part of renowned organizations such as GSK, Seagen and PATH/Bill & Melinda Gates Foundation, he got to design, advise on and oversee the execution of dozen of nonclinical regulatory programs. JF is familiar with regulatory agencies worldwide, including USFDA, EMEA, Indian, Indonesian and Chinese FDA. As an example, acting as the nonclinical expert for Serum Institute of India, JF defended their pneumococcal vaccine candidate (now marketed as Pneumosil™)-clinical dossier before the Indian FDA in New Delhi in person on two occasions. JF was also involved in the nonclinical regulatory work which ultimately led to the licensing, first by the FDA, and then by the EMA, of Adcetris®, an Antibody-Drug Conjugate indicated for refractory lymphomas.
Services
GRTC provides comprehensive regulatory and product development consulting services for all types of nonclinical programs:
IND-enabling and other toxicity studies, Pharmacokinetics (PK), ADME, Genetic, Safety pharmacology
Nonclinical Regulatory Strategy Development
For:
- Vaccines
- Therapeutic monoclonal antibodies
- Antibody-drug conjugates (ADC)
Including :
- review of existing nonclinical development plans (gap analysis) or design from scratch
- pre-filing regulatory agencies interactions worldwide, including pre-IND meetings
Study Implementation
Together with the CRO of your choix, we take care of studies, including:
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- CRO audit and selection
-- design (protocols)
- in life monitoring (critical steps audits according to your specifications)
- real-time data analysis and reporting
Reports review and finalization
Regulatory Submission to local agency
Dossier Preparation & Submission follow up:
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- Nonclinical sections of INDs and NDAs writing
- Investigator’s Brochures co-writing
- Clinical protocol co-writing as needed
- Written and oral interactions with local regulatory agency at any time over the course of product development