Consulting

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Consulting indicates both the industry and practice of helping organizations improve their performance primarily through the analysis of existing business problems and development of plans for improvement. This is not the same as customer service.. We streamline the compliance process and consulting with the help of industries experts, best practices, Quality, regulation for Medical Device companies, Pharmaceutical, biotechnology and health care services.

Our dedicated areas include:

Medical Devices: The keen areas wherein we provide the best covers Quality Management, Validation, 510(K), ISO 14971 & ISO 13485, Recall, Electronic Records, System Based Inspection, Documentation, Software validation, GMP, Quality System Regulation, Design Control and Device Listing.

 

Pharmaceutical: Most common areas include compliance consulting by experts for FDA Validation, GXP, 21 CFR part 11, Computer Validation, Audit and Inspection,GMP, GCP, Packaging/labelling ,Drugs and Biologics and Drug Manufacturing.

Health care: Most common areas of Healthcare Compliance are Ethics Compliance,HIPAA, Healthcare Information, Healthcare, Patient safety, Health insurance, Health care billing ,Medical Record System & Audits for healthcare industries.

Biotechnology: Most common areas of compliance training by compliance experts are: Validation, USP 111, GMP Bioassays, cGMP, QbD, E2500 Biological products, Microbial excursions, Biologics, Water System Contamination, CAPA, Risk Assessments, Cell Culture, Water System Compliance, Drug Marketing Compliance, and GEP & Biotech Regulated based seminars.

More of the areas that we aspire to concentrate involve:

  • Aviation
  • Energy and utilities
  • Food and beverage
  • Financial services
  • Manufacturing

Thus we commit to our customers an efficient and effective way of delivering the same.





 

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  • Howard T. Cooper
    President
  • David N. Muchemu
    Founder and CEO
  • Jasmin NUHIC
    Sr. Manufacturing Engineer
  • Charles H Pierce
    President
  • J. Jeff Schwegman
    Founder and CEO
  • Robert J. Russell
    President & CEO
  • Jim Sheldon-Dean
    Founder
  • Angela Bazigos
    CEO of Touchstone Technologies Silicon Valley
  • Calin Enea Popa
    Founder and President
  • Jeff Kasoff
    Director of Quality
  • Lee Truax Bellows
    Founder and CEO
  • Glenda Guest
    Vice President
  • Alex Aptovcov
    Senior Clinical Research Consultant
  • David Nettleton
    Computer System Validation’s principal
  • John Chapman
    Medical Device Consultant
  • Angela Polania
    CPA, CISA, CRISC
  • Connie Valencia
    Principal
  • Jan Seal
    International Trade Consultant
  • Hedley Rees
    Consultant
  • Dan O’Leary
    President of Ombu Enterprises
  • James Russell
    Director, Regulatory Affairs for RJR Consulting, Inc
  • Dr.David Lim
    Ph.D
  • Peter Welch
    CEO and founder of Sox International Inc
  • On Demand Webinars
  • Jennifer Bill
    Director of Global Regulatory Affairs
  • Henry Urbach
    Management Consultant
  • Asaad A. Faquir
    Compliance Officer
  • Barry O’Brien
    Consultant
  • John Avellanet
    Founder & Managing Director Cerulean Associates LLC
  • David R. Dills
    Regulatory Affairs & Compliance Consultant
  • Dr. Linda Yang
    Associate Director
  • Evan P. Phelps & Casper E. Uldriks
    Consultants
  • Casper E. Uldriks
    Consultant
  • Neil O Flaherty & Stephen Terman
    Ofwlaw
  • Teresa Preziosi
    Principal Consultant
  • Harry Huss
    Chief Compliance Officer
  • Mr. Luis Chavarria
    Ex FDA Investigator
  • Fred Richman
    Director
  • Steven Walfish
    Founder and President of Statistical Outsourcing Services
  • Moe Alsumidaie
    President and Chief Scientific Officer
  • Michael Barile
    Founder and Managing Partner
  • Richard Chamberlain
    PHD
  • Melinda Allen
    Independent Food Safety and Quality Assurance Consultant
  • Norma Skolnik
    Regulatory Expert
  • Michael Swit
    FDA & Regulatory Expert
  • Kim Huynh-Ba
    Chief Compliance Officer
  • Kimberly Kiner
    FDA Expert
  • Kenneth J. Christie
    Chief Operating Officer
  • Evan P. Phelps
    Principal Attorney
  • Stephen D. Terman
    Principal Attorney
  • Neil F. O'Flaherty
    Principal Attorney
  • Jonathan M. Weinrieb
    Principal Attorney
  • Karl M.Nobert
  • Dr. Kosta Makrodimitris
    Director & Adviser
  • Julian Wilkins
    VP PharmaConsult US, Inc
  • J. MASON WEEDA
    Regulatory Expert
  • Dr Vladimir Shnaydman
    President
  • Betty Lane
    Founder and President
  • Bradley Johnson
    Owner and Principal of BN Johnson Consulting, LLC

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