|
 
      
  
|
|
Track I /
DEFINE
REGULATORY
STRATEGY and SUBMISSION PREPARATION
Track I/Define provides tools for managing a full range of comprehensive
regulatory services, including the determination and development of
optimal regulatory and clinical protocol strategies for streamlined
review and incorporation in successful submissions, including IDE, 510(k),
PMA, and HDE.
In
addition, Boston Biomedical Associates can act as an FDA liaison for
key communications, presentations, and meeting participation critical
to the approval process.
Med•D4™
can guide you through the regulatory process with ease, helping to minimize
regulatory burdens and accelerate product time to market.
 |
|
-
FDA liaison
- Pre-IDE
Preparation
- Regulatory
& Clinical Protocol Development
- Clinical
Design
- Labeling,
Promotion
- Due
Diligence
- SOP
Preparation
- Facility
Registration
|
|
Let
Boston Biomedical Associates and Med•D4™
guide
you through the challenges of the regulatory process with ease, helping
to minimize regulatory burdens and accelerate product time to market.
Download
Track I literature
Contact
Us
Call our Massachusetts office at 866-351-8632 (In MA 508-351-8632)
M-F
8-5 eastern time or e-mail
us and we’ll contact you directly.
BOSTON
BIOMEDICAL ASSOCIATES
386 West Main Street, Suite 7 · Northboro, MA 01532
Tel. (508) 351-8632 · Fax: (508) 351-8637
©2007 Boston Biomedical
|
|
