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16313 Jousting Terrace
Sydney Gilman, Ph.D., is a former FDA Chemistry reviewer. He spent 6 years at FDA in various CDER Therapeutic Drug Divisions of the Center for Drug Evaluation and Research with consulting ties to both Biologics and Devices. Dr. Gilman also has an additional 20 years of experience in the pharmaceutical industry in positions ranging from Senior Scientist to Director to Vice President Responsibilities. He earned his Ph.D. in Organic Chemistry from the University of Pittsburgh.
Trident's combined experience in FDA and the Pharmaceutical Industry in Regulatory Affairs and Quality, addresses many therapeutic areas in primarily CDER, CBER and CDRH. Trident is interested in assisting companies in planning strategies, resolving Regulatory issues, as well as preparing and publishing Regulatory packages, inclusive of NDAs and NDA supplements, INDs and IND amendments, VGDSs, DMFs and MAFs, CTDs, Briefing documents, complete Regulatory responses, and communications that require General Correspondence filings.
Trident is a specialty Regulatory/Compliance group situated near the FDA Headquarters in Maryland. We offer a wide range of regulatory/compliance services tailored to the needs of smaller and mid-sized innovative healthcare companies. We are able to develop regulatory/compliance strategies, liaise with FDA and other Regulatory Authorities, perform due diligence, complete gap analyses, carry out GXP functions, prepare technical documentation and compile and submit global regulatory submissions. Trident can work with your document management system and produce high quality CTD formatted submissions. We encourage you to ask about filing eCTD documentation. We have an established electronic submission gateway to FDA and are capable of working with secure electronic links to all its individual clients.
Trident has extensive experience in working on the Regulatory hurdles and opportunities associated with 510K and PMA programs as well as CDRH enabling activities leading to successful regulatory actions at FDA. Additionally, Trident is very active working with FDA and clients in defining critical paths that utilize independently microdosing or genomics.
Services: ·Regulatory Strategy Development for drugs, biologics and devices
·GXP Quality Services (GMP/GLP/GCP auditing, mock inspections, due diligence qualifications of facilities, vendor certification and strategic development)
·Due diligence activities in support of the sale or purchase of a product
·FDA Submission Planning and Development (VGDSs, INDs, NDAs, 510Ks, PMAs, CTDs, ANDAs, Paper NDAs, Annual and Periodic Reports, DMFs and MAFs)
·Regulatory Documentation Publishing
·FDA Liaison Activities
·Consultation on CMC issues
·Regulatory opinions on Clinical, Nonclinical and Medical Device Issues
·CMC Report Writing
·Regulatory Review of Clinical, Nonclinical, and CMC Documentation
·Regulatory Review of Medical Device Documentation
·On-site seminars and training
Introducing the parallel track initiative to meet the expectations of the Critical Path as dictated by Global Regulatory Authorities, FDA, EMEA, and PDMA
**Important Note This information has been provided by the Company and has not been confirmed by Contract Laboratory Inc. It is recommended that you confirm all information prior to using this Company.
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