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Do you have an upcoming New Drug Application or Investigational New Drug Application, but not the in-house staff to do it? Do you need someone to manage your application, as well as plan and prepare it?
PharmSupport is pleased to offer our unique TotalService Submissions system, which can provide you with full service and with the manpower and expertise to handle all aspects of your regulatory submission. Each of our submissions experts averages at least 8 years of scientific, regulatory, and submissions experience, and each has at least one unique area of expertise that collectively form the basis of a complete and thorough application.
Following are just some of the expertise and services we can offer as part of our TotalService Submissions system:
Medical Writing
Our experienced Medical Writers create strong documents that present your data in a clear and concise manner, and that support your intended product label. Our Medical Writers also have experience with electronic submissions and can prepare documents compatible with electronic publishing software.
Project Management
Our experienced Project Managers recruit staff, create timelines and budgets, and define submissions goals specific to your project. Our Project Managers also liaise with you and with the various team members to ensure smooth communications and harmonized messages throughout your application.
Statistical and Programming Services
Our experienced Statisticians and Statistical Programmers create and implement strong Statistical Analysis Plans that support project goals. Our statisticians and statistical programmers also have experience with electronic submissions and can prepare output compatible with electronic submissions and electronic publishing software.
Regulatory Oversight
Our experienced Regulatory experts can help you to prepare for meetings with FDA, and can attend meetings and liaise with FDA according to your needs. These experts also oversee the preparation and compilation of your IND or NDA, including electronic submissions, to ensure that your application will meet the regulatory standards expected by FDA.
Medical Consultation and Review
Our experienced Project Physicians answer medical questions from the submissions team and helps the team to interpret and meaningfully analyze and write about complex medical issues. Our Project Physicians can also review documents for medical accuracy and offer consulting services to proactively identify issues that need to be addressed from a medical standpoint.
Other Expertise
PharmSupport has access to a number of experts in areas such as pharmacology, toxicology, pharmacokinetics, chemistry, and manufacturing. These team members can provide expert consultations and prepare strong documents supporting your overall submissions goals. Likewise, PharmSupport can liaise with your Regulatory group, or with your electronic publishing group or vendor, to compile your New Drug or Investigational New Drug Application, or can identify and liaise with suitable vendors to compile your paper or electronic submission.
PharmSupport understands the urgency of most applications and offers a quick turnaround time on your applications. PharmSupport also offers personalized service, by a highly motivated and experienced team. We can also train your staff in the submissions process, so that they will be able to create high-quality submissions either now or in the future!
Please contact PharmSupport, Chandra Louise, or Fred Smith to discuss our unique system and how we could help you!
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