xfda.com
FDA submission consultantsWe are 40 FDA Consultants all former FDA experts in fda submissions and regulatory affairs, medical devices, pharmaceuticals, biologics etc...
http://www.xfda.com/
We are 40 FDA Consultants all former FDA experts in fda submissions and regulatory affairs, medical devices, pharmaceuticals, biologics etc...
http://www.xfda.com/
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DDRS LLC
Kumar Chittipeddi
N●A
N●A , NA, 00000
US
View this contact
DDRS LLC
Kumar Chittipeddi
N●A
N●A , NA, 00000
US
View this contact
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FDA submission consultants | xfda.com Reviews
https://xfda.com
We are 40 FDA Consultants all former FDA experts in fda submissions and regulatory affairs, medical devices, pharmaceuticals, biologics etc...
xfda.com
Quality systems
http://www.xfda.com/quality-systems.html
Can supply you with the appropriate FDA conforming documentation and training. Our Quality System solutions are tailored for your organization. Medical Devices/In Vitro Test Kits:. Can organize and execute an entire system or a particular subsystem to meet the FDA QSR compliance. Inspections: Our approach to cGMP quality system implementation for biologic and pharmaceutical manufacturers (21 CFR Part 210 and 211) complies with FDA's Compliance Program. Contact us to discuss your project and requirements.
Global
http://www.xfda.com/global.html
Inspections - GMP, GCP and GLP. Do you need help with? Inding the right P. Classification of your medical device. FDA Registration and Listings. Do you need to register? Contract Manufacturers and Contract Sterilizers. Reprocessors of Single Use Devices. Do you need help with? Category III CPT Codes.
Medical officers
http://www.xfda.com/medical-officers.html
Clinical and regulatory physician has both an M.D. and Ph.D. and is board certified in Neurology and Clinical Neurophysiology. The expert is an MD with an MPH in Epidemiology. The expert is an MD board certified in Internal Medicine and held positions with the FDA for 8 years and now consults in the domains of drugs, biologics and devices. MD with Board Certifications in Internal Medicine and Infectious Diseases. MPH Biostatistics/ Epidemiology Track. Inspections - GMP, GCP and GLP. Do you need help with?
Regulatory affairs
http://www.xfda.com/regulatory-affairs.html
Consultants will complement your organization to provide diverse regulatory solutions, including diverse product profiles and submissions for review and endorsement by the authorities such as FDA and other International Regulatory Authorities. Consultants provide our clients direction through the entire regulatory submission process. Provides the following Regulatory Services:. Medical Devices and IVD Submissions. Investigational Device Exemption (IDE). Pharmaceuticals and Biologics Submissions.
FDA submission consultants
http://www.xfda.com/medical-devices.html
FDA Consultants - Medical Devices. Our FDA medical device consultants were involved with the regulation of devices while at the FDA. We are able to help with appropriate medical device classification to determine the correct regulatory path required for your medical device. Having the xFDA. Team working with you will help you through the process to deliver our services on time and within budget. Medical Device Experts Have Wide And Varied Experience. Devices used in Neurosurgery, Neurology, and Psychiatry.
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FDA submission consultants
CONTRACT SERVICES/REVIEW AND ADVICE. Consulting provides contract services for the approval of Drugs, Biologics and Medical Devices by the Food and Drug Administration (FDA). Consists of more than 70 consultants formerly FDA experts involved in the drug, biologic and medical device approval processes. We offer a wide range of advice and services from preclinical trials, drug, biologic and medical device development, clinical trial protocols and support through the approval process and beyond. Experts can...
FDA Mock audits conducted by FDA consultants Perkins and Perkins, Inc. GCP TRAINING,COMPLIANCE ISSUES, PREVENT 483'S RESPOND TO 483'S, NEGOTIATE WITH FDA, PRE IND, PRE IDE OR 483
Looking for FDA Assistance? Let a former FDA Medical Officer help you. Dr Perkins has successfully worked with pharmaceutical and medical device companies. Dr. Perkins saved sites from getting 483s, propelled non-approval products to market, helped get first patient into clinical trials, negotiated labeling issues and helped companies resolve 510k and PMA issues. By asking companies the right questions, Dr. Perkins has saved companies time and money with regulatory strategy.
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