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Our Capabilities

PRE-APPROVAL AUDITS:
Let us help you avoid that 483 with:

Mock FDA Inspections
Prepare for FDA inspection
Clinical QA (Quality Assurance) Audit
GCP (Good Clinical Practice) Compliance audit
Due diligence audit
Safety Reviews help companies assess their study sites


TRAINING IN GOOD CLINICAL PRACTICES (GCP)
Let a former FDA Medical officer

Train your staff at your site and your convenience
Assess your program on or off site for FDA compliance


PREPARATION FOR MEETINGS
Let a former "Insider" help you with:

FDA meetings - you need to get a "yes" from FDA
Investigator meetings - if your investigators do not follow the protocol-
you loose money.
FDA Advisory Panel Meetings - you want approval.


FDA SUBMISSION STRATEGY
Dr. Perkins has "regulatory eyes" let her help with your
Getting to YES with FDA

Review and evaluate your clinical program for FDA filing
Assist in the preparation of : IND, NDA; IDE, PMA, 510(k);
Drug/Device and Biologic/Device Submission.
Should 510k or PMA be filed
Review Adverse Event Reports for FDA filing
Review and Evaluate Safety Summaries
Identify Regulatory Issues in your submission; work with you on
solutions to issues; prepare your team to negotiate with FDA; interpret FDA
regulations, guidelines, and policies.


CLINICAL STUDY DESIGN
Let a former FDA reviewer help with your

Write Clinical Protocols, Case Report Forms (CRF's), the Label, Informed
Consent Forms, Patient Packet Inserts (PPI)
Advise on need for Data Safety Monitoring Committee.
Get that first patient into the clinical study, review data for FDA approvability,
IND, IDE


(c) 2008 All rights reserved -Perkins & Perkins Incorporated
 
 
Dr. Jerri Perkins
         CV>
  
 
             

Consultant, FDA, Food and Drug Administration, FDA consultant, FDA audit preparation, fda, FDA Consultant, FDA,(c) 2008 All rights reserved -Perkins & Perkins Incorporated 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