• ​​​​​​​​​FDA Submissions & Compliance
 
  • Drug Development & Clinical Trials
 
  • IRB Selection and  Submissions
 
 
  • Site Setup & Inspections
 
  • Risk Assessment & Training
 


Links

http://www.fda.gov/RegulatoryInformation/default.htm


http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/default.htm

http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

 


Organizations 

5 Tainter Street, P.O. 437
Peapack, New Jersey 07977
(973) 936-9444
​abeer@myhealthlaw.com

Abu Judeh Health Law LLC, Provides Health Law Compliance And Regulatory Guidance

Clinical Development Processes & Regulatory Compliance


Our services include developing educated drug approval plans; preparing and filing FDA packets; participating in key organizational meetings; as well as providing compliance oversight review and advice. ​

Project Oversight As Well As CRO, SMO Management

​​
Our professionals can assess and determine your legal and clinical needs and then negotiate with medical services providers including IRB, PI, Clinical Manufacturing Organizations (CMO), Clinical Research Organizations (CRO), Site Management Organizations (SMO), clinical data management software, laboratories and financial partners to protect your interest. We can further manage and audit those services to ensure regulatory and study design compliance.