|
|
 |
|
 |
|
|
"The project team’s skill, dedication, flexibility (and tolerance) were pivotal to the success of this program. When the program needed to make significant changes to adapt to shifting program conditions, they never complained they just accomplished their job. Over my career I have worked with many groups on NDA, BLA and PMA studies. I would have no hesitation in using inVentiv Clinical and their team. Despite their size (perhaps because of it) they succeed on programs that many larger groups would totally fail."
— Vice President of Regulatory
Affairs & Quality Assurance
Large Pharmaceutical Company
|
|
|
|
|
|
|
|
|
|
 |
|
|
|
|
| Fortune Magazine rates inVentiv Health #15 of the Fastest Growing Companies. |
|
|
|
|
|
|
|
|
|
|
|
|
 |
|
|
|
|
|
|
|
|
|
| At inVentiv Clinical, we are experienced in virtually every nuance of interaction with regulatory bodies, from developing pre-clinical strategies through final submissions as well as audit support and quality program development. Before helping you create the blueprint for your product's regulatory program, we thoroughly assess existing product literature and the competitive and regulatory environment to define the most expeditious approach to obtaining registration. We can also provide comprehensive regulatory guidance to smaller biotechnology and medical device companies unfamiliar with the complex regulatory environment. |
|
Regulatory Services |
|
|
|
| • |
Paper/electronic submissions for drugs/devices/biologics |
| |
| • |
IND, IDE, NDA, PMA, BLA, 510K |
|
| • |
Agency interaction/liaison |
| |
| • |
Pre-IND/IDE meetings, end of Phase II meetings, pre-NDA/PMA/BLA meetings |
|
| • |
DSMB participation |
| • |
FDA Advisory Board presentation support |
|
|
|
|
|
Quality Assurance Services |
|
|
|
| • |
Development of quality plans, systems, programs and documentation |
| • |
Conduct of quality system GMP/GCP audits in preparation for FDA inspections (for clinical study sites and manufacturing facilities), and assistance in responding to FDA observations |
| • |
Conduct of contract vendor/supplier audits |
| • |
Computer system validation and software development activities |
| • |
Development and delivery of GMP/GCP training |
| • |
Conduct of risk analysis/risk assessment exercises |
|
|
|
|
|
| For more information on our internal quality systems and processes, visit the Quality Policy section of our website. |
|
| Download our Regulatory Fact Sheet |
|
|
|
|
|
|
