Syner-G Pharma CMC Consulting, LLC

Description

Address: 2 Park Central Dr #110, Southborough, MA 01772 Phone: (508) 460-9700: : : Hours: : Category: : : Place name: Website: Website: http://www.synergpharma.com/ Category: Consultant Suggest an editUnable to add this file. Please check that it is a valid photo. Unable to add this file. Please check that it is a valid photo. · Own this business?Add missing informationAdd business hours Unable to add this file. Please check that it is a valid photo. Questions & answers Ask a questionBe the first to ask a question Add a photoThanks for sharing!Your photo will be posted publicly on Google.Contribute MoreDoneUpload public photos of Syner-G Pharma Consulting Posting publicly on the Web Write a review Reviews Be the first to review

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Syner-G Pharma CMC Consulting, LLC Employees

Employee
Years
Job
Industry
Hiral Gutka Hiral Gutka Dover, Ohio Details
Hiral Gutka's Syner-G Pharma CMC Consulting, LLC Experience November 2012 - April 2014
Job Regulatory Affairs Associate at Zimmer
Industry Medical Devices
Experience
Zimmer  April 2014 - Present
Syner-G Pharma CMC Consulting, LLC   November 2012 - April 2014
Bulfinch temporary services - TIMI study group   August 2012 - November 2012
Bristol-Myers Squibb, Princeton, New Jersey   February 2010 - April 2010
Merck  February 2009 - January 2010
B. Braun Medical  June 2008 - December 2008
Pfizer  May 2007 - June 2007

Skills
Team Leadership, Organizing, Detail Orientation, Documentation, Clinical Trial..., Clinical Data Management, Data Entry, CTMS, CMC Regulatory Affairs, IND, Software Documentation, Regulatory Affairs, CMC, Regulatory Submissions, GMP, Validation, GLP

Education
Northeastern University   2010 — 2012
Masters, Regulatory Affairs for Drugs, Biologics and Medical Devices

Dr. B. N. College   2004 — 2008
Bachelor in Pharmacy, Pharmacy

Shan Huang MS (RA), RAC Shan Huang MS (RA), RAC Greater Boston Area Details
Shan Huang MS (RA), RAC's Syner-G Pharma CMC Consulting, LLC Experience December 2013 - Present
Job Sr. Regulatory Affairs Specialist at SynerG Pharma CMC Consulting, LLC
Industry Pharmaceuticals
Experience
Syner-G Pharma CMC Consulting, LLC   December 2013 - Present
AstraZeneca  2007 - 2012
Millennium Pharmaceuticals  2004 - 2006

Skills
Drug Discovery, Medicinal Chemistry, Organic Synthesis, Regulatory Affairs, Drug Design, Sop, Clinical Research, CMC Regulatory Affairs, Project Management, Analytical Chemistry, Quality Control, GMP, Compliance Audit

Education
Northeastern University   2011 — 2013
MS, Regulatory Affairs of Drugs, Biologics, and Medical Devices

The Ohio State University
Master's degree, Organic Chemistry

Sindhura Gaddamanugu Sindhura Gaddamanugu Greater Boston Area Details
Sindhura Gaddamanugu's Syner-G Pharma CMC Consulting, LLC Experience April 2013 - April 2014
Job Regulatory Affairs Specialist at Ocular Therapeutix, Inc.
Industry Pharmaceuticals
Experience
Ocular Therapeutix, Inc.   April 2014 - Present
Syner-G Pharma CMC Consulting LLC  April 2013 - April 2014
Novartis Consumer Health  August 2012 - March 2013
Northeastern University  2010 - 2012
Aurobindo Pharma  August 2009 - August 2010
Dr. Reddy's Laboratories   June 2009 - June 2009
Trident Pharmaceuticals Ltd   June 2008 - June 2008

Skills
IND, NDA, ANDA, MAA, Register, Informed Consent, Medical Devices, Biologics, Risk Management, CE marking, SPL, Food & Drug Law, MDR, Formulation, PMA, Regulatory Submissions, ICH-GCP, Product Development, CMC Regulatory Affairs, 510(k), Drug Listing, Publishing, eCTD, Regulatory Operations, Pharmacovigilance, FDA, Validation, Regulatory Affairs, Clinical Trials

Education
Northeastern University   2010 — 2012
Master's degree, Regulatory Affairs for Drugs, Biologics and Medical Devices

Jawaharlal Nehru Technological University   2006 — 2010
Bachelor's degree, Pharmacy

Prabu Nambiar Prabu Nambiar Greater Boston Area Details
Prabu Nambiar's Syner-G Pharma CMC Consulting, LLC Experience September 2011 - Present
Job Principal at SynerG Pharma CMC Consulting, LLC
Industry Pharmaceuticals
Experience
Syner-G Pharma CMC Consulting, LLC   September 2011 - Present
U.S. Pharmacopeia   September 2010 - Present
AVEO Oncology  January 2012 - July 2012
Vertex Pharmaceuticals  April 2008 - August 2011
AAPS  2007 - 2009
Cubist Pharmaceuticals  2005 - 2008
Wyeth Pharmaceuticals  2004 - 2005
Sepracor  1998 - 2004
Bristol-Myers Squibb  1991 - 1998

Skills
Regulatory Affairs, Pharmaceutics, CMC, Pharmaceutical Industry, Quality by Design, Drug Development, Regulatory Submissions, Technology Transfer, FDA, GMP, Biopharmaceuticals, Biotechnology, Regulations, Clinical Development, Product Development, CMC Regulatory Affairs, GLP, Validation, Quality Assurance, Drug Discovery, Sop, Commercialization, Clinical Trials, Change Control, Lifesciences, Drug Delivery, Analytical Chemistry, Clinical Research, IND, Medical Devices, CAPA, V&V, 21 CFR Part 11, Regulatory Requirements, HPLC, Computer System..., Management, Quality System, Compliance, Vaccines, Formulation, Pharmacology, GxP, Science based..., Applied Regulatory..., Genotox Impurities, SOP, Life Sciences

Education
Boston University - School of Management   2003 — 2004
Executive MBA, Business Administration and Management, General

Brown University   1988 — 1991
Post-Doctoral Training, Organic / Bio-organic Chemistry

Oregon State University   1983 — 1988
Ph.D., Organic Chemistry

Madras University   1977 — 1982
BSC, MSc, Chemistry

Binesh Prabhakar Binesh Prabhakar Greater Boston Area Details
Binesh Prabhakar's Syner-G Pharma CMC Consulting, LLC Experience September 2012 - Present
Job Partner at Cambridge IT Compliance LLC.
Industry Pharmaceuticals
Experience
Cambridge IT Compliance LLC.   March 2013 - Present
Syner-G Pharma CMC Consulting LLC  September 2012 - Present
Histogenics  November 2012 - March 2013
Ziopharm Oncology  November 2012 - January 2013
Vertex Pharmaceuticals  October 2011 - September 2012
Vertex Pharmaceuticals  September 2008 - October 2011
My Piece Of Chennai   January 2010 - July 2010
Bunker Hill Community College  August 2008 - April 2010
Cignus Solutions LLC   2005 - January 2009
Wyeth  2006 - 2008

Skills
Entrepreneurship, Change Management, Strategic Planning, Consent Decree, Quality Assurance, Quality System, Laboratory Automation, Regulatory Guidelines, FDA, FDA GMP, 21 CFR Part 11, 21 CFR, Computer System..., Infrastructure, network qualification, ITIL, GAMP, System Design, System Testing, Business Requirements, Trackwise, Documentum, Argus Safety, ARISg, SAP, Oracle Applications, Biotechnology, GxP, GMP, Validation, Lifesciences, Change Control, Drug Development, CAPA, LIMS, Regulatory Requirements, Quality Auditing, Medical Devices, Quality Control, Technology Transfer, Sop, Pharmaceutical Industry, SOP, TrackWise, Life Sciences

Education
Babson College - Franklin W. Olin Graduate School of Business   2010 — 2012
Fast Track MBA

Texas A&M University-Corpus Christi   2002 — 2004
Masters of Science, Environmental Science

University of Madras   1996 — 2000
Bachelors in Engineering Degree, Electronics and Communication

St Bede's Anglo Indian Higher Secondary School   1983 — 1993
Higher Secondary

Darshika Doshi, MS, RAC Darshika Doshi, MS, RAC San Francisco Bay Area Details
Darshika Doshi, MS, RAC's Syner-G Pharma CMC Consulting, LLC Experience February 2013 - May 2014
Job Senior Associate, Clinical Regulatory Affairs at BioMarin Pharmaceutical Inc.
Industry Pharmaceuticals
Experience
BioMarin Pharmaceutical Inc.  February 2015 - Present
BioMarin Pharmaceutical Inc.  May 2014 - February 2015
Syner-G Pharma CMC Consulting, LLC   February 2013 - May 2014
Packard Consulting   November 2012 - February 2013
Cubist Pharmaceuticals  October 2012 - February 2013
Cubist Pharmaceuticals  January 2012 - October 2012
Amgen  July 2011 - October 2011
INFOCOMMONS, Northeastern University  September 2010 - July 2011
Ranbaxy Laboratories Ltd. , Dewas, India   June 2009 - July 2009
CHL- Apollo Hospital, Indore   July 2008 - July 2008

Skills
Regulatory Affairs, Online Communications, SOP, GMP, IND, Clinical Trials, Regulatory Requirements, Excel, Microsoft Office, Document Management, CRO, Auditing, eCTD, Sop

Education
Northeastern University   2010 — 2012
Masters, Regulatory Affairs

Rajiv Gandhi Prodyogiki Vishwavidyalaya   2006 — 2010
Bachelor's, Pharmacy

Choithram School   1999 — 2005

Venkata S Varanasi, M.S Venkata S Varanasi, M.S Greater New York City Area Details
Venkata S Varanasi, M.S's Syner-G Pharma CMC Consulting, LLC Experience March 2014 - May 2014
Job Regulatory Affairs Associate at RiconPharma LLC
Industry Pharmaceuticals
Experience
RiconPharma LLC  May 2014 - Present
Syner-G Pharma CMC Consulting, LLC   March 2014 - May 2014
MCPHS University  August 2013 - May 2014
MCPHS University  January 2013 - May 2014

Skills
ANDAs, DMF, Annual Reports, eCTD, Regulatory Operations, Regulatory Submissions, Adobe Acrobat, ISI Toolbox, Regulatory Affairs, Regulatory Filings, Quality Assurance, Change Control, Medical Devices, Microsoft Word, Microsoft Excel, ANDA, cGMP practices, FDA, 21 CFR, Pharmaceutical Industry, Regulatory Requirements

Education
Massachusetts College of Pharmacy and Health Sciences   2013 — 2014
Master's Degree, Regulatory Affairs and Health Care Policy, 4.0/4.0

Andhra University   2008 — 2012
Bachelor's degree, Pharmacy, 3.53/4.0

Barbara Staples Barbara Staples Greater Boston Area Details
Barbara Staples's Syner-G Pharma CMC Consulting, LLC Experience August 2015 - Present
Job Project Management, Program & Laboratory Management, Technical Development
Industry Biotechnology
Experience
Syner-G Pharma CMC Consulting, LLC   August 2015 - Present
Biogen Idec  May 2012 - February 2014
Biogen Idec  January 2009 - May 2012
Biogen Idec  January 2004 - January 2009

Skills
Biotechnology, 21 CFR Part 11, Technology Transfer, GxP, Validation, Computer System..., Change Control, LIMS, FDA, GMP, Pharmaceutical Industry, Formulation, Purification, Cell Culture, Biopharmaceuticals, Life Sciences, Drug Development

Education
Rutgers University   1982 — 1986
Bachelor's degree, Chemistry

Rutgers University-New Brunswick

Ankitha Rao Ankitha Rao Greater Boston Area Details
Ankitha Rao's Syner-G Pharma CMC Consulting, LLC Experience January 2013 - April 2013
Job Senior Specialist at Regulatory and Quality Solutions LLC (R&Q)
Industry Medical Devices
Experience
Regulatory and Quality Solutions LLC (R&Q)   July 2015 - Present
R&Q  February 2014 - July 2015
Philips Healthcare  July 2013 - February 2014
Syner-G Pharma CMC Consulting, LLC   January 2013 - April 2013
Arteriocyte  June 2012 - December 2012
SERVOMAX INDIA LIMITED   April 2010 - May 2012

Skills
Regulatory Affairs, Quality Assurance, Quality Control, Regulatory Submissions, CE marking, FDA, Medical Devices, GMP, CAPA, Quality System, 21 CFR Part 11, Clinical Research, Biotechnology, Regulatory Requirements, IND, SOP

Education
Northeastern University   2011 — 2013
Master's degree, Pharmacy Administration and Pharmacy Policy and Regulatory Affairs, 3.7

Jawaharlal Nehru Technological University   2007 — 2011
Bachelor's degree, Pharmacy

Anuradha Balasubramanian Anuradha Balasubramanian Greater Boston Area Details
Anuradha Balasubramanian's Syner-G Pharma CMC Consulting, LLC Experience May 2014 - Present
Job CMC RA consultant at SynerG Pharma CMC Consulting, LLC
Industry Research
Experience
Medical Discovery Partners LLC   June 2015 - Present
Syner-G Pharma CMC Consulting, LLC   May 2014 - Present
Syner-G Pharma CMC Consulting, LLC   November 2013 - April 2014
Harvard Medical School  July 2007 - October 2013
Boston Children's Hospital  July 2007 - October 2013
Beth Israel Deaconess Medical Center  February 2001 - June 2007
NII - National Institute of Immunology  July 1999 - January 2001

Education
University of Madras   1995 — 1999
Doctor of Philosophy (Ph.D.)

University of Madras   1994 — 1995
Master's degree

Casey Costello Casey Costello Rochester, New York Area Details
Casey Costello's Syner-G Pharma CMC Consulting, LLC Experience September 2014 - Present
Job Associate Director Regulatory Affairs at SynerG Pharma CMC Consulting, LLC
Industry Pharmaceuticals
Experience
Syner-G Pharma CMC Consulting, LLC   September 2014 - Present
Bausch + Lomb  January 2010 - Present

Skills
GMP, Validation, Pharmaceutical Industry, FDA, R&D, Medical Devices, Regulatory Affairs, Technology Transfer, CAPA, Aseptic Processing, Biotechnology, Regulatory Submissions, GCP, Clinical Trials, Pharmaceutics, Quality System

Education
University of Michigan
Masters

University of Michigan
Bachelors

James R. Bush, MBA James R. Bush, MBA Greater Boston Area Details
James R. Bush, MBA's Syner-G Pharma CMC Consulting, LLC Experience September 2015 - Present
Job Senior Manager Regulatory Affairs at SynerG Pharma CMC Consulting, LLC
Industry Pharmaceuticals
Experience
Syner-G Pharma CMC Consulting, LLC   September 2015 - Present
Vertex Pharmaceuticals  March 2013 - August 2015
Vertex Pharmaceuticals  April 2012 - March 2013
Infinity Pharmaceuticals  June 2011 - April 2012
AMAG Pharmaceuticals  August 2010 - June 2011
AMAG Pharmaceuticals  January 2009 - August 2010
Vertex Pharmaceuticals  February 2008 - January 2009
Vertex Pharmaceuticals  July 2005 - February 2008

Skills
HPLC, Analytical Chemistry, Pharmaceutical Industry, Validation, Chromatography, Technology Transfer, Chemistry, Gas Chromatography, Quality Assurance, Microbiology, Quality Control, Method Development, Clinical Development, Biotechnology, CAPA, GMP, Drug Discovery, Regulatory Affairs, Analytical Method..., Drug Development, GxP, 21 CFR Part 11, Laboratory, CMC, Change Control, IND, Regulatory Submissions, FDA, UV/Vis, CRO, LC-MS, Sop, Bioanalysis, Assay Development, SOP

Education
Babson College   2011 — 2015
Master of Business Administration (M.B.A.), Business Analytics and Healthcare

Union College   2001 — 2005
Bachelor of Science, Biochemistry

Robert Gadimian Robert Gadimian Greater Los Angeles Area Details
Robert Gadimian's Syner-G Pharma CMC Consulting, LLC Experience December 2014 - Present
Job Sr. Director at SynerG Pharma CMC Consulting
Industry Pharmaceuticals
Experience
Syner-G Pharma CMC Consulting, LLC   December 2014 - Present
Puma Biotechnology  November 2011 - Present
Johnson & Johnson  May 2007 - March 2012
Abraxis BioScience  2005 - 2007
Amgen  2004 - 2005
Abbott Laboratories  2002 - 2004
Fresenius Kabi  February 1998 - April 2002
MPA (Meical Prouct Agency)   April 1997 - February 1998

Skills
IND, eCTD, CMC, Regulatory Submissions, Regulatory Requirements, Regulatory Affairs, FDA, Regulations, Pharmaceutical Industry, Drug Development

Education
Uppsala universitet   1992 — 1996
Ms. in Pharmacy, Pharmacy

Temple University

Maura Maloney Maura Maloney Greater Boston Area Details
Maura Maloney's Syner-G Pharma CMC Consulting, LLC Experience December 2013 - April 2015
Job Associate Director at Ironwood Pharmaceuticals
Industry Pharmaceuticals
Experience
Ironwood Pharmaceuticals  April 2015 - Present
Syner-G Pharma CMC Consulting, LLC   December 2013 - April 2015
Amarin Corporation  February 2010 - November 2013
GTx, Inc.   March 2007 - February 2010
Alkermes  January 1997 - February 2007
Seragen  August 1993 - January 1997

Education
Harvard University   1999 — 2003
Master's degree, Biology, General

Boston University
Bachelor's degree, Biology, General