Regulatory Consulting for Biologics

Preparing/Filing Investigational New Drug Applications (INDs)
Planning Global Regulatory Strategies
Reviewing NIAIDs Grant Funding
Providing Training programs on various regulatory topics
Preparing due-diligence reports
Planning transfer of manufacturing facilities
Managing FDA Inspections
Responding to FDA's 483 report

Activity:

- Regulatory Affairs & Legal Services

Product / Technology type(s) covered:

- Bio
- Diagnostics
- Generics
- Prescription drugs (Rx)

Therapeutic targets:

- AIDS
- Hematology
- Infectious Diseases

Markets Covered

a. HeadQuarter: United States of America

b. Continent(s) active: Europe , North America , Asia

c. Countries active: US, EU, Korea, India, Indonesia

Corporate data:

Number of Employees: 4

Turnover:

Amount:	Year:	Currency:
$500,000	2002	US Dollar

Year founded: 1999

Partners / Alliances: Pharmaceutical Companies, Venture Fundings Agencies, Investigational Review Boards (IRBs), Clinical Investigators