For the Pharmaceutical, biotech, device or life science industries....
What makes the difference in preparing for the FDA meeting where you need to defend your studies? Well, what comes into the mix to prevent a “yes, however, not quite ready for approval”. Nothing more, than a jaundiced eye to review the material to see how better to present it to the FDA. Here, just a quick phone call to Medi-
Temps, USA will bring a well performing specialist with the track record for preparing your team for their successful NDA preview. Our specialists have brought tittering programs onto sound ground and received “overwhelming approval status” from the FDA. We have Consultants for Design and implementation of Phase I-IV clinical studies. Still others designed animal models for preclinical development. Consultants for EMEA pediatric submissions DMSB. Our trained and successful consultants have done Technology and Pharmacoeconomic assessments. Many have done extensive medical writings including sections of IND, NDA, and BLA applications. Many have been Medical reviewers for clinical trials! Our Consultants have prepared Manuscripts, abstract and done medical/clinical presentations. Many have developed Investigator’s meetings. Their working knowledge has extensive interactions with KOL's. They have developed extensive interactions with sales and marketing departments. Some have successfully developed the creation of medical/clinical databases. Others have had major roles in Clinical Development. Still others have held major positions in Medical Affairs roles. When they have completed their assignments, you will call them, "Heaven sent!"! We call them your “Bottom line enhancers!"
So make the call and open the track for success. If you are not familiar with our company and your first contact
with us is online, we would be pleased to hear from you! Please let us know what your needs and questions are,
we will be more than happy to help. Our regular customers particularly value our rapid turn around time supplying the right person the first time. Our business is located at :
980 Post Road East
2nd Floor
Westport, CT 06880
Office- 203-227-3688
[email protected]
**Please, visit only by appointment!
