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Silay Regulatory and Medical Consulting
SILAY CONSULTING provides services for the approval of Drugs and Medical Devices by the Food and Drug Administration (FDA). SILAY CONSULTING consists of several consultants formerly FDA and Pharmaceutical experts involved in the drug and devices approval process. We offer a wide range of services from preclinical and clinical trials and drug development through approval and quality inspections in USA, Europe and Turkey.
Premium pharmaceutical business services
Strategic Regulatory Planning
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Coordinating FDA interactions, activities and meetings
Coordinating and reviewing all technical, scientific and medical documentation
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Submitting and defending regulatory applications
Preparing and submitting sNDAs, Periodic Reports and Annual Reports
Reviewing advertising and promotional materials
World-class consulting services from planning and design of the approval process through the United States Food and Drug Administration
Performing professional independent mock FDA audits/ inspections using the latest quality inspection techniques in USA, Europe and Turkey.
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14 Ash Drive
Neptune New Jersey 07753
United States
Attn: Yavuz S. Silant
ph: 732-485-7191
fax:
cell:
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