 In
support of our mission and to elevate the knowledge of regulatory
guidelines, Amarex has published a series of books related to ICH/FDA
guidelines. To download the PDF versions of these guidelines, please
register with us by clicking here.
Amarex has a special
and unique insight into the workings, procedures, and requirements
of the FDA. This unique insight comes from years of experience working
for and with the FDA.
This insight, together with our successful experiences
in completing all phases of clinical trials from design through
submission, successful defense, approval of several U.S. NDAs, PMAs,
and European Marketing Applications, afford Amarex the knowledge
and experience to successfully guide your project from concept through
completion.
We know how critical it is to assure a sound regulatory
strategy, trial design, and regulatory communication from the concept
stage of a clinical trial. Our team is comprised of regulatory professionals
with many years of experience
either working for or with the FDA. Team members have years of drug
and device development experience. Our experts have presented to
more than 30 FDA advisory committees both as FDA representatives
and as sponsor representatives. They have worked on numerous NDAs,
PMAs, 510Ks, representing different classes of drugs and devices.
AMAREX expertise, in conjunction with your staff’s
expertise, ensure desired product approval and product labeling
through the appropriate studies. We work with you in developing
proper documentation and integrated reports to establish the safety
and efficacy of your product.
Amarex Regulatory Affairs Services:
• Site Audits
• Contract Research Organization Audits
• Standard Operating Procedure Development
• Regulatory submissions
• U.S. Food and Drug Administration contact
• Serious Adverse Event Reporting
| Advantages
of AMAREX regulatory affairs:
• FDA experience
• Numerous FDA Advisory Committee presentations
• Submitting and defending multiple successful NDA, PMA,
and 510K
• Submission, successful defense, and approval of European
Marketing Applications
• Thorough knowledge of FDA/ICH guidelines |
|
