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GG Pharma Consulting, INC. - President and CEO

Name: GG Pharma Consulting, INC. - President and CEO
Address: 239 Main Street, East Greenville, PA, 18041, US
Telephone: +14843637774
Price range: $$

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East Greenville, PA
GG Pharma Consulting, INC. - President and CEO

Providing Consultancy & Contract services (full-time, short-term, long-term, on-site, virtual office with favorable outcome.

Over 19 years of experience in Clinical Research & the Pharmaceuticals/Biotech & CRO industry as a seasoned Professional/Executive within Quality Assurance (GxPs), Quality Control (Phase 1 - Phase IV Studies), Global Clinical Site Monitoring, Quality Management Systems (QMS), Computer System Validation, Inspection Readiness, Reg. Affairs/Submission Dossier, PV/Safety Surveillance, Vendor Managemen

t & Oversight, Project Management (PM) & as a Sub-Investigator (SI). Summary of Experience:
Currently President/CEO at GG Pharma Consulting, INC. (GGPCI) a Consulting Firm highly specialized in Clinical QA, Global GxP Audits, Quality Control, Site Monitoring, Inspection Readiness etc.). Successfully directed the Global QA & QC program for multiple Therapeutic Areas by applying compliance and risk-based principles (pro-active versus re-active approach) during audits of clinical trials & Quality Control reviews of Clinical Trial related-documents. Have been in charge of the Global Audit program for > than 75 pivotal regulatory submissions from start-to-end resulting in the regulatory approval of several block buster drugs. Subject Matter Expert (SME) in leading Inspection Readiness Activities/Mock Inspections, Sponsor Audits, Internal Audits, Systems Audits, Internal Quality Control reviews, External Audits, Vendor Management/Oversight, Compliance Training and Hosting Regulatory Inspections (> than 160 - Site, Sponsor-Monitor, CRO) by FDA, EMA MHRA, ANMAT etc. Responsible for leading and setting-up the QA department in start-up company & big pharmaceutical firms.

01/05/2020

Jan2010-Jan2020_Happy 10th Anniversary GG Pharma Consulting Inc. (GGPCI)
Pharma Consulting, INC. Corporate Office
In a blink of an eye we made it as a Niche ‘Boutique’ Clinical Research Organization (CRO) to 10 years in operations. When I founded the company as part of ‘Women in Leadership & Entrepreneurship’ in Jan 2010 I never dreamed of this incredible Global journey we would be on.
GGPCI was immediately recognized by Large Global Pharmaceutical Companies & CROs to be Credible & have the Clinical Research, Good Clinical Practice, Quality Assurance & Regulatory, Inspection Readiness expertise/skills set to support pivotal studies.

A sincere thank you to all my Sponsors/Clients who believed & continue to believe in GGPCI.
But in particular to the GGPCI Team and Hindi, Payel & Dan & Pooja who worked towards the success of GGPCI
Our motto is: Quality not Quantity
We continue to deliver the highest quality of work at GGPCI with full dedication to improve the life of many sick patients whose hope is to have that one novel drug discovery and approval allowing them: To Live Longer & Have a better Quality of Life!
Cheers & Happy New Year to all.

Gayatri Girwarr (GG), MD
President & CEO
GG Pharma Consulting Inc. (GGPCI)
Gayatri Girwarr
————————-/————————————
GGPCI for 10 yrs. successfully provided oversight to Sponsors (Pharmaceutical Companies & CROs) & directed the Compliance programs for High & Medium complex clinical trials (US & ex-US) leading to several drugs/devices/biologics Approvals.

This was achieved by (but not limited to):
-Scientific, Medical & Regulatory Reviews of Clinical Study Protocols
-QMS (Quality Management Systems), Continuous Improvements
- Risk-Based Approach, Risk Mitigation, Risk-Based Monitoring (RBM)
-End-to-end Quality resulting in several blockbuster drug/ biologics & devices approvals) & recipient of several awards
- Specialize in Oncology, Neuroscience, GI, Cardiology, Dermatology, Women’s Health, Genetics (Gene therapy/Gene Modification)
-Conduct routine GCP & GxP (ISA, eTMF, Vendors/CRO, BioAnalytical Labs, e-Vendors, Data Integrity, Phase I Units,
- Inspection Readiness, Sponsor-Monitor Mock Inspections, Host/Lead Regulatory Inspections US & ex-US FDA, EMA, MHRA, ANMAT, ANVISA, PDMA etc.
- Conduct for-cause & Confidential Audits)
- Workshops & GCP training
-Extensive Site Management/Site Monitoring experience
- Clinical Study Lead/ Sr Site Manager
-SOP Review, Writing and Gap Analysis
- Issue & CAPA Management etc.

05/24/2018

24May2018: As the President/CEO of GG Pharma Consulting, INC. & the Board Members It gives me great pride & honor to announce that the Clinical Research Operations has moved to Scottsdale, Arizona.

09/01/2014

GG Pharma Consulting, INC. (GGPCI) Bulletin Board - 01Sep2014:
Happy Labor Day from GG Pharma Consulting, INC. to all GGPCI Staff, Business Partners, Sponsor/Clients & Workers in the USA.
I thank my staff sincerely for another year where we are exceeding our 2014 goals & objectives only because of your hard work & dedication. We excelled in the number of Phase-I Units Clinical Assessments & Qualification for Bioequivalent & Bioavailability studies, Proof of Concept and PK/PD Studies) & added GMP as a full GxP service area in 2014 & had non-stop activities/API audits/Quality Agreement reviews/SOP writing etc. due to the commitment & dedication of GGPCI's Sr. GMP Consultant Ray P.
We try to deliver and live by GGPCI's Mantra:
Do you work with your whole heart & passion & you will succeed!
For there is so little competition when it comes to such work ethics.
Cheers to the next 3 months until end of the fiscal year.
I continue to be grateful to you all.

Sincerely - GG
Gayatri Girwarr (GG), MD
President & CEO
GG Pharma Consulting, INC

01/26/2014

GG Pharma Consulting, Inc. (GGPCI) Bulletin Board - 25Jan2014
Happy New Year to All! As of 01Jan2014 GG Pharma Consulting Inc. (GGPCI) Corporate office has moved into a new suite with a more spacious reception area & larger offices located in the same Historical District complex we first moved into in Aug 2012 (239 Main Street (29N), East Greenville, PA). May I extend a sincere thank you to all GGPCI Pharma Clients/Partners. GGPCI couldn't have grown & expanded without your support & trust in our Clinical Research Services, Good Clinical Practices (GCP)/GxP, on-going newly awarded projects & above all repeat business. I am also happy to announce that as of Jan2014 GGPCI has added full scope cGMP services to our deliverables to help you meet regulatory requirements & to have highly standardized process controls be applied to the earliest phases of Research & Development through the commercialization/marketing of your products (e.g., New Drug Approval/Medical Device etc.). Thank you to our Clients who have awarded us with the GMP projects.

A warm thank you to Hindi Girwarr for remodeling the entire new GGPCI suite from installing new carpet, redoing the employee break room with such a modern look & great choices of soothing color schemes throughout the office !

Gayatri Girwarr (GG), MD
President & CEO
GG Pharma Consulting, INC.
—

12/02/2013

GG Pharma Consulting, INC (GGPCI) Bulletin Board - (GG 01Dec2013)
Best wishes for a 'Happy Holiday Season' and our sincere thanks to our Sponsors/Clients/Clinical Staff/Business Partners for your loyalty & goodwill throughout the year 2013 which has made it another successful year for GG Pharma Consulting, INC. (GGPCI). We feel energized & optimistic to work more diligent and harder in 2014 to meet your expectations as we enter our 5th year of operations & are expanding moving into a bigger Suite. THANK YOU FOR ALL YOUR SUPPORT WE COULD NOT HAVE DONE IT WITHOUT YOU!
HAPPY HOLIDAYS :-)
Sincerely - GG
Gayatri Girwarr (GG), M.D.
President & CEO
GG Pharma Consulting, Inc.(GGPCI)
239 Main Street Suite 101 & 102A & B
East Greenville, PA 18041
Office Phone: 267-923-5132 / Fax: 610-845-0994
Cell: 484-363-7774
E-Mail: [email protected]

09/05/2013

GG PHARMA CONSULTING, INC.
We strive to provide: The best Good Clinical Practices (GCP) End-to-End Clinical Research Consulting Services ranging from Quality Assurance, Monitoring of Global Clinical Trials & Regulatory Compliance to ensure the data collected is reliable and credible to help in the Cinical Development, Approval & Marketing of novel & break-through therapies (i.e., hard to treat cancers, auto immune & cardiovascular diseases etc.) to improve Patients' Quality of Life!
Gayatri Girwarr (GG), M.D.
President & CEO
GG Pharma Consulting, Inc.(GGPCI)
239 Main Street Suite 102 A & B
East Greenville, PA 18041
Office Phone: 267-923-5132 / Fax: 610-845-0994
Cell: 484-363-7774
E-Mail: [email protected]

08/25/2013

GG Pharma Consulting, INC (GGPCI) Bulletin Board - (GG 25Aug2013)
GGPCI Executive Management Team would like to extend a "Warm Thank You" to our Sponsors/Clients for making it possible for our company to enter into the 5th year of operating & providing Consulting Services to Clinical Research & Development, Clinical Operations, Regulatory Compliance, Regulatory Submissions & Inspection Readiness etc. We moved from our previous location to our Corporate Office in East Greenville, PA on 20 Aug2012 & are now occupying this location for the 2nd year & expanding.

The six most important words that I have learned in the Business world are: I admit I made a mistake.
The five most important words: You did a good job!
The four most important words: What is YOUR opinion?
The three most important words: If you please :-).
The two most important words: Thank You.
The one most important word: We
AND THE LEAST IMPORTANT WORD: "I" (as that doesn't exist in GGPCI's vocabulary)
Our sincere gratitude to our Sponsors/Clients for awarding us with projects and repeat business.
GGPCI will work harder to present your deliverables in the fastest yet highest quality possible.
Kind Regards - GG
Gayatri Girwarr (GG), MD
President & CEO GGPCI

07/31/2013

My personal commitment to my Business Partners/GGPCI Staff, Sponsors/Clients at GG Pharma Consulting, INC. but above all to the 'Patients' (who rely upon us to oversee the Quality Assurance, Monitoring & Regulatory Compliance of clinical trials & ensure the data is reliable) is to continue to work diligently in Clinical Research & Development. My Goal is to help make your days as productive & your 'Quality of Life' as great as I aim mine & for my loved-ones & associates to be! "Thank You" all for being the enormous support (Chicken Little you too) & having GGPCI been awarded with several new great projects in Jul2013 & to know we won these bids with a competitive edge. I will continue to work hard to uphold this challenge & remain the best for you! Happy Fall To All! Sincerely - GG
Gayatri Girwarr (GG)
President & CEO
GG Pharma Consulting, Inc. (GGPCI)
239 Main Street Suite 102 A & B
East Greenville, PA 18041
Office Phone: 267-923-5132 / Fax: 610-845-0994
Cell: 484-363-7774
E-mail: [email protected]

03/23/2013

GG Pharma Consulting, INC Bulletin Board - (GG 23Mar2012)
CONGRATULATIONS to GGPCI’s Exec. Management Team & Staff for going into the 4th year of our Clinical Research & Development operations & for Such Major Accomplishment achieved in 1Q2013:
It is with great ‘JOY & PRIDE’ that I share that GG Pharma Consulting Inc. & Staff Members have been nominated as the #1 Clinical Service Provider by GGPCI’s Major Sponsor Pharma Client in their monthly publications & news Letter of Jan2013, Feb2013 & Mar2013 distributed worldwide. We were recognized for majorly improving their Quarterly Quality Metrics (1Q2013) & bringing the percentage of outstanding critical & major compliance issues at high-enrolling investigational sites from over '90%' open & outstanding >than 90 days to '0%' outstanding & all resolved effectively within l< than 30 days. The Client individually recognized me on Tue 19Mar2013 but I collectively recognize all my staff hereby. Without all your hard work I could have never accomplished all this in such record breaking time!!! Last week was 1 of the craziest. Each one of my staff member & I worked around the clock (~24/7) without a significant break. Yet we were determined to give our Client the best & WE (GGPCI) DID! CONGRATS & you will be rewarded by me & the CFO Hindi Girwarr! I couldn’t be more proud & honored to be working with you all - GGPCI's A-Team! I commend your Excellent Work Ethics!
Sincerely - GG

Gayatri Girwarr (GG), M.D.
President & CEO
GG Pharma Consulting, Inc.
239 Main Street - Suite 102 A & B
East Greenville, PA 18401

01/26/2013

GG Pharma Consulting, INC Bulletin Board - (GG 25Jan2013)
I shared this simple message today in my Staff meeting with my personnel: To Teach is to Learn Twice (2x)!
Every time you do mentor, lecture, guide or help some one at work or in the business to better understand a project, product, program, a medical test/procedure or Standard Operating Procedure (SOP) you increase you own knowledge exponentially as you will challenge yourself to be at your best! NOW TRY IT OUT!

Gayatri Girwarr (GG), MD
President & CEO
GG Pharma Consulting, Inc.
239 Main Street - Suite 102 A & B
East Greenville, PA 18401

01/10/2013

GG PHARMA CONSULTINGt, INC. - GGPCI is working harder in 2013 with motivated & skilled Clinical Research Staff available 24/7 Globally to meet your high expectations to deliver Quality Data for your Drug/Device Approval & Innovative Breakthrough Gene Therapy for hard-to-treat Cancers) & to be:
- Efficacious but above all have a well monitored Safety Profile to help many patients lead a better Quality of Life for Chronic Diseases that may otherwise be disabling & limiting.
Give us your Trust and we give you Results!

Gayatri Girwarr (GG), MD
President & CEO
GG Pharma Consulting, Inc.
239 Main Street - Suite 102 A & B
East Greenville, PA 18401

Address

239 Main Street
East Greenville, PA
18041

Opening Hours

Monday	9am - 5pm
Tuesday	9am - 5pm
Wednesday	9am - 5pm
Thursday	9am - 5pm
Friday	9am - 5pm

Telephone

+14843637774

Website

http://www.ggpharmaconsulting.com/

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