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DP Clinical is A ROCK              Accountable: guarantee quality of work              Reliable: high employee retention rate              Offer: proactive suggestions              Committed: to 100% client satisfaction              Knowledgeable: expertise, experience and education
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Services & Capabilities


  • Monitoring
  • Data Management
  • Biostatistics
  • Medical Writing
  • Quality Assurance
  • Regulatory
  • Pharmacovigilance

Regulatory -DP Clinical draws on its valuable experience in planning and managing submission of essential documents in order to move projects forward. We understand the importance of meeting tight deadlines and rely on our skills and experience in communicating with the client.

Our regulatory affairs team offers clients a wide array of services, including:

● Prepare recruitment and subject information materials
● Prepare Informed consent form
● Response to FDA requests for information during development
 of clinical investigations
● Regulatory advice to address warning letters, 483 (s), recalls, and other 
compliance issues
● Safety and pharmacovigilance reporting
● Vendor Qualification
● Review and maintenance of documentation and records
● Review of advertising and promotional materials
● Technical writing including clinical study reports and investigator's brochures

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


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9201 Corporate Boulevard, Suite 350 | Rockville, MD 20850 | P (301) 294-6226 | F (301) 294-4561 | dpinfo@dpclinical.com