8806 LIBERTY LANE ° POTOMAC, MARYLAND 20854
° 301-983-0395 °

 
  HOME ::      

 
 

 
 
                                                                                                               + A | - A



 
DRUG EXPERIENCE DEVICE EXPERIENCE
   
Responding to 483s to prevent Warning Letters
In-house GCP Training saves companies money
IND - getting 1st patient into clinical trials IDE - Working with investigators to follow the protocol
NDA- propelling non-approval to approval PMA- that pre-FDA critique "helps"
Pediatric studies offer unique challenges but there are rewards. 510k - is it a 510k or a PMA?
Labeling - issues can make or break your product
Safety Review can identify site issues and prevent clinical holds.  

 

 

 

 


(c) 2008 All rights reserved -Perkins & Perkins Incorporated

 
 
 
Quick Link
   
 
 
             

Consultant, FDA, Food and Drug Administration, FDA consultant, FDA audit preparation, fda, FDA Consultant, FDA, Food and Drug Administration, FDA consultant, FDA audit preparation, fda, FDA Consultant, FDA, Food and Drug Administration, FDA consultant, assistance in writing protocols for FDA, FDA regulatory strategy planning, fda consultant, FDA case report forms, FDA applicaton, FDA approval, FDA labeling advice, clinical trail design, advice and preparation of FDA informed consent, FDA patient package inserts, PPI, advice on fda data safety  monitoring board, fda consultant, fda consulting, FDA IND, FDA approval, FDA IDE, fda clinical program evaluation, FDA IND, FDA NDA, FDA IDE, FDA PMA, fda 510(k), fda adverse event report reviews, FDA ISS and IES review and evaluation, fda medical consulting, fda regulatory consulting, GCP Workshops, EXPERT FDA, expert fda, fda medical device consulting, fda consultant, fda approval, fda medical device consulting, fda consultant, fda approval, fda medical device consulting, fda consultant, fda approval, fda medical device consulting, fda consultant, fda approval, fda medical device consulting, fda consultant, fda approval, AIDS, Alzheimer's, Anti-Infective, Cardiovascular Drugs and Devices, Dermatology, GI, Generic Drugs,  Neuropharmacological, Pulmonary Drugs, Barrier Devices, FDA Approval, AIDS Prevention, Drug Device Combinations,  Dental Devices, Gene Therapy, General and Plastic Surgery Devices, GI/GU Devices, Imaging, Lasers,  Neurological and Radiological Devices, OB/GYN, Ophthalmic Devices, fda consultant, Orthopedic Devices, FDA Good Clinical  Practices (GCP) Reviews, assessment for FDA compliance, fda advisory panel preparation, Drug Consultants, Pharmaceutical Consultants, GCP Consultants,  fda regulatory strategy, fda audit preparation, fda pre-approval audit preparation, fda clinical trials, mock FDA inspection, Clinical Quality Assurance Audit, Clinical QA Audit,  Assistance with Clinical Audit, assistance with clinical audit, Pre-FDA Audit, Pre-FDA Inspection, FDA audit, FDA inspection, FDA Medical Consultants in MD, FDA Medical Consultants in Maryland, FDA Regulatory Consultants in MD, FDA Regulatory Consultants in Maryland,  GCP Compliance audit, Good Clinical Practice Compliance Audit, Clinical Trials consuntant, Clinical audit experience, former FDA, FDA meeting consultant, FDA drug consultant, FDA drug development, FDA Medical Consultants in DC, FDA Medical Consultants in Washington, DC, FDA Regulatory consultants in Washington, DC, FDA Regulatory consultants in DC