BLOG.SILAYCONSULTING.COM
WELCOME TO SILAY REGULATORY AND MEDICAL CONSULTING , LLC
WELCOME TO SILAY REGULATORY AND MEDICAL CONSULTING , LLC
We have a genuine interest to learn about our customers in a one on one phone and preferrably face to face setting to seek out the strategies and solutions for your pharmaceutical or biotechnology FDA approval needs. We carefully listen and learn about your issues, the procedures you perform and your preferred way of strategy to bring you new horizons and solutions in an innovative way.
We value the expertise and skills of your company executive and review carefully the programs to find ways to make them succesful in an expedited manner with utmost professionalism.
We have a genuine interest to learn about our customers in a one on one phone and preferrably face to face setting to seek out the strategies and solutions for your pharmaceutical or biotechnology FDA approval needs. We carefully listen and learn about your issues, the procedures you perform and your preferred way of strategy to bring you new horizons and solutions in an innovative way.
We value the expertise and skills of your company executive and review carefully the programs to find ways to make them succesful in an expedited manner with utmost professionalism.
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
You can put your trust in SILAY CONSULTING.
SILAY CONSULTING is a biopharmaceutical consulting firm that assists clients in the navigation of regulatory issues and government submissions,particularly in the areas of US, European and Turkish drug development and registration,
Orphan product designation, Regulatory strategy, Dossier preparation, Project management, Pharmacovigilance, Regulatory and medical compliance from early stage development to post marketed products.
We provide personal service and exceptional quality. Our unparalleled service, competitive prices, and overall value are why our loyal customers won't go anywhere else. We look forward to serving you!
The name you can trust!
SILAY CONSULTING has two offices in St. Louis and New Jersey
14507 BANTRY LANE, Apt #4, Chesterfield, Missouri 63017
14 ASH DRIVE, Neptune, New Jersey 07753
(732) 485-7191 silay@silayconsulting.com
SILAY CONSULTING is a biopharmaceutical consulting firm that assists clients in the navigation of regulatory issues and government submissions,particularly in the areas of US, European and Turkish drug development and registration,
Orphan product designation, Regulatory strategy, Dossier preparation, Project management, Pharmacovigilance, Regulatory and medical compliance from early stage development to post marketed products.
We provide personal service and exceptional quality. Our unparalleled service, competitive prices, and overall value are why our loyal customers won't go anywhere else. We look forward to serving you!
The name you can trust!
SILAY CONSULTING has two offices in St. Louis and New Jersey
14507 BANTRY LANE, Apt #4, Chesterfield, Missouri 63017
14 ASH DRIVE, Neptune, New Jersey 07753
(732) 485-7191 silay@silayconsulting.com
Thursday, February 26, 2009 12:32 AM
Examples of services that are offered;
Submission strategy, preparation and support for investigational and marketing applications(IND, NDA, ANDA, sNDA, CTD, Drug Master Files
Applications for Orphan Drug Designation
Clinical study design and Regulatory drug development strategies
Life cycle management initiatives
Required regulatory report development and preparation, such as IND and NDA Annual Reports, promotional material review and submission, NDC drug listing, adverse event reporting
Post marketing publication and regulatory affairs support for recalls and product issues
Establishment of procedures to ensure regulatory compliance
Day to day clinical and regulatory affairs operations and guidance
INQUIRIES? CONTACT US AT silay@silayconsulting.com
or call 732-485-7191 for any of your firms consulting needs,
as we will provide you with a free, no-risk assessment
or call 732-485-7191 for any of your firms consulting needs,
as we will provide you with a free, no-risk assessment
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