Office:
103 Carnegie Center, Suite 103
 
Princeton, NJ 08540,USA
Phone:
(609) 799-0021
Fax:
(609) 497-9695

We offer our regulatory expertise on all continents and our track record speaks for itself.



 

 



Looking for global help and support ?

We can do it.

 


Traditional Global Outreach

The pharmaceutical industry has largely avoided registration and launch of new products in emerging markets until well after filing and approval in major markets, i.e. EU and US.

The complicated and often nontransparent regulatory environment of Asia Pacific, Latin America, and Central and Eastern Europe has caused reluctance to pursue early launch in these regions. As a result, new therapies are, at best, late to market in these countries.

Regulatory Support of Clinical Programs

In today's global environment, multi-center multinational trials are not only becoming practical but almost mandatory. Obviously, top quality multinational research requires experienced medical and regulatory support. This includes pre-trial assessments of the regulatory environment, familiarity with the timelines, understanding the issues with shipments of investigational products, GCP expertise, mechanisms for safety reporting, and many other details. This is especially important in markets with little tradition of GCP-based trials. We offer our medical and regulatory expertise on all continents and our track record speaks for itself.

Support of Marketed Products

Companies have to prioritize their activities and they concentrate most of their resources on the support of new products. This leaves little time and attention for older, mature products that have been on the market for years. Nevertheless, these products still need to be reregistered, labels updated, safety reports summarized and filed, manufacturing information updated. Looking for help and support? We can do it.

Educational Services

Do you want to expand your reach to new markets and you need regulatory advice on how to go about it?

What about training your local office employees about drug development? Good Clinical Practice? You can do it - but do you have the time and resources?

Special Projects

We have accumulated extensive experience on the regulatory due diligence process when it comes to acquisitions of one or more products or even complete companies. We have also experienced mergers and extensive manufacturing network changes, with all the regulatory work that results.

What if you are out-licensing your products? Or thinking about co-marketing or co-promotional agreements? We have done it - call us!


 

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