Consulting 
 Regulatory Services
    
 Submissions (IND, NDA, BLAs) to US, Europe, ROW (Rest of World)
 DMF (Drug Master Filing) – preparation and filing
    
 Compliance Services
    
 Audits – GMP
 Equipment Qualification (installation, operation, performance)
 Protocols and Procedures
    
  Validation Services 
 Validation Master Planning
 Equipment Validation
 Facility Validation
 Cleaning Validation
    
  Professional Development Courses  
 Good Manufacturing Practices (cGMP)
 Good Laboratory Practices
 Good Clinical Practices
 Virus Clearance Strategies for Biopharmaceutical Safety
 Drug Development Cycle
 Process Validation
 Downstream Processing
 
( Additional courses can be designed and tailored to suit your requirements )
 
  Scientific/Technical Writing 
 Scientific manuscripts, review articles, ‘How To’ Guides on specialized topics and book chapters
 Medical Communications
 Educational materials preparation – content development and design
 Training and presentation materials including e-learning module for:
   >    Sales and marketing
   >    Technical professionals
 
  Testing and Analytical Services  
 Compendial tests
 Toxicology tests
 Cell line characterization and banking
 Method development
  Method validation
 
  Liaison Services We have an excellent network of consultants and CROs in US, Europe, and Asia including emerging markets like India and China. Please contact us if you are interested in outsourcing contract manufacturing and contact testing.
 

Contact Us :
e-mail: hazel@gaeainc.com
Phone: 631-261-4665

Attn: Hazel Aranha
GAEA Resources Inc.
P.O. Box 428,
Northport, NY 11768