Welcome! We would like to gather specifics about your skill set before arranging a phone call. Please tell us about how great you are using the fields below. This should take less than two minutes to complete.

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Username & Password
 * ?
Passwords must be > 6 characters with one capital, number or special character.
About You
 * ?
Please use this field for the commonly used last name.
Preferred Method: *  Email   Phone
Best Time:  *  AM   PM   Evening   Anytime
This is the name which you do business under, as applicable. If no business name is identified, payments will be made to individual persons.
Biosketch: ?
The biosketch may include: 'Consultant is a GxP auditor with X years' experience in..' or 'Consultant specializes in FDA regulatory guidance and intelligence'. Use no more than two (2) paragraphs, with no more than six (6) sentences each.
This short document will represent and market you in a honest way. This is your personal brand creating a good first impression. It should grab the reader's attention, make the reader want to know more. Focus on your skill set, what you have to offer, how you got to this point in your career, and why you are reliable and trustworthy. Write in third-person and do not use your name or the name of the previous companies for which you worked.  * Detailed Instructions here
(Maximum characters: 1250) characters left.
Competency Category (check all that apply): ?

Audit/Compliance focused - Please use this category if you have worked as a Quality Assurance or Compliance professional.

Regulatory or Medical Writing focused - Please use this category if you have worked as a Medical Writer or Regulatory professional.

Technical Pharmacovigilance (PV) focused - Please use this category if you have worked as a Safety, Medical Monitor or Surveillance professional.

Please use the options below to best describe your experience. Each category reveals additional service types, be sure to check the relevant category to document all competencies. Note: If you uncheck a category box any data entered will be lost. *

 Audit/Compliance focused

 Regulatory or Medical Writing focused

 Technical Pharmacovigilance (PV) focused


1) Growth Area:    Have participated as co-resource only, had limited or no experience in this area. I would like to attend at no cost with an experienced professional.

2) Competent:      Have conducted routine scoped audits/services infrequently in this area. (e.g., <5 per year but a minimum of 5-11 audits as lead).

3) Adept:               Have consistently conducted audits/services with a varied scope in this area. (e.g., 3-10 years and a minimum of 12-25 audits as lead).

4) Expert:              Have specialized experience in this area conducting complex and/or for-cause audits/services consistently. (e.g., >10 years or lead 26 or more audits).

Service Type


Growth Area *1

Competent *2

Adept *3

Expert *4

Acting as an Expert Witness

Agency Guidance and Remediation

Compliance Risk Evaluation


Food and Supplements

GcLP/ CLIA Clinical Laboratories

GCP Investigator Site Audit

GCP Phase I

GCP Trial Master File

GLP Animal Facility

GLP Non-Clinical Laboratories

GMP Biologics/Vaccine

GMP Device Facility

GMP Drug Facility

GxP Computerized Systems

GxP Document – clarify as CSR, NDA, TLFGs, Dossiers, IB ?

Auditing of documents such as CSR, NDA, TLFGs, Dossiers, IB. If you have created these materials only, please do not use this competency but refer to the Regulatory technical options.

GxP Mock Inspection

GxP Quality Management System Gap Analysis

GxP Training

GxP Vendor (that is not a specified in this list)

Independent Consulting ?

Experience as an Independent Consultant.

ISO Implementation ?

Implementing standards such as 13485, 14971.

Post-Marketing Pharmacovigilance

Pre-Marketing Pharmacovigilance

REMS and Post-Authorization Studies Auditing

Sponsor-level Inspections



Agency Interactions/Meetings ?

Pre-Submission, Q-Submission meeting attendance.

Aggregate Reporting Creation/Review

Clinical Evaluation Report Creation/Review

Design Dossier Creation/Review

External Patient Materials Creation/Review

Human Factors Engineering Creation/Review

IND Creation/Review

Label Creation/Review

NDA Creation/Review

Periodic Reporting Creation/Review

REMS and Post-Authorization Study Creation/Review

Risk Assessment and Management Creation/Review

Strategic Advice and Planning

Submission Preparation/Review ?

Across any classification: Software (standalone device, decision support, MDDS); In-Vitro Diagnostic (IVD); Combination Products; Medical Device.

Technical File Creation/Review

Aggregate Safety Reporting Creation/Review

Literature Searching

Medical Information Computerized Systems Implementation/Review

Post-Approval Reaction Processing/Reporting

Pre-Approval Safety Case Processing

PV Master File Compilation/Review

PV Risk Management Creation/Review

REMS and Post-Authorization Studies Creation/Review

Signal Management and Monitoring Activities

Employment History:  * Have you worked at a Global Health Authority Agency?     Yes     No
Therapeutic Area Experience: * Select the areas for which you have experience or knowledge
 None Specifically
 Dental and Oral Health
 Ear Nose Throat
 Family Medicine & Sleep
 Gastroenterology and Urology
 General and Plastic Surgery
 Genetic Disease
 Infections and Infectious Diseases
 Obstetrical and Gynecological
 Ophthalmology & Otolaryngology
 Pulmonary & Respiratory Diseases
Certifications: * ?
Enter the name of the professional certification (RAC, RQAP, ISO, Qualified Person) that is not based on University education such as a Master's Degree or PhD. Education details shall be requested later.

(You must fill out all the fields for each line in order for that line to be saved.)

e.g. RQAP

e.g. 2013
Certification is current? Yes   No
Certification is current? Yes   No
Certification is current? Yes   No
Certification is current? Yes   No
Certification is current? Yes   No
Certification is current? Yes   No
Certification is current? Yes   No
Certification is current? Yes   No
Certification is current? Yes   No
Certification is current? Yes   No
Education: *

Check all that apply. If your degree type is not listed, please choose the most similar equivalent.

Degree Details here
Location Experience:  * Use the options below to indicate where you have conducted services in the past 10 years. Choose all that apply. ?
Click the link for a list of countries aligned by region.
Click here to view the countries vis-a-vis regions
Australia And Islands
Central America
East European Union
Middle East
North America
South America
The Carribean
West European Union
Language Skills:  * ?

Basic indicates that you can read, write and speak at an elementary education level.

Proficient indicates that you can read, write and speak in a professional setting.

Fluency indicates an advanced level of understanding, use of regional differences and idioms.

Use the options below to assign your language skills.

(no testing is required)



Basic/Limited *1

Proficient *1

Fluent/Native *1

Speaking Only

Reading and Speaking Only





Indian languages

Nordic languages



1) Reading, Writing, Speaking

  Yes     No   I am interested in a long-term (months) dedicated assignment ?
Dedicated assignments are those where you would be working 40 hours per week for a dedicated client/project.
  Yes     No   I am interested in a short-term (weeks) dedicated assignment ?
Dedicated assignments are those where you would be working 40 hours per week for a dedicated client/project.
  Yes     No   Are you interested in full-time, permanent employment opportunities? ?
NEW: You may be contacted by our business partner about opportunities suited to your skills.
Final Step
Almost done, please upload your CV and click the submit button. *

By submitting this form, I consent for FDAQRC to use and maintain the personal information supplied to conduct business. I have access to this information and can make corrections at any time. FDAQRC manages this data, does not share this data externally except for the purposes for conducting business and has security measures in place to protect the data. Data will be stored until such time that it is requested to be removed in accordance with applicable international regulations.