Pharmaceutical Quality Assurance Consulting 

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Pharmaceutical & Biotech Consulting
Provide professional consulting services applicable throughout the pharmaceutical, biotechnology and biologics product lifecycles.
www.PT-Resources.com
QA Services
Proven QA expertise for any technology product.
www.provare.com
Pharmaceutical Consulting
Premier consulting firm serves the world's top 20 Pharma companies.
www.campbellalliance.com
ISO 9001 Certification
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Quality Assurance Plans
Get Integrated Quality Solutions, Support & Implementation Services!
ThinkQuality.com
Call Center Consulting
QA Programs, Training, Coaching ROI-driven assistance and advice
www.HyperQuality.com
Pharmaceutical Consultant
FDA Approval for Drugs, Compliance Call Us: Industry Experts/Ex-FDAers
www.PhoenixRising.com
Cost Reduction Consulting
Optimize savings and profits with innovative strategic planning
www.us.capgemini.com/CostManagement
Regulatory Affairs
Pharmalink Consulting - Global Regulatory Affairs Consultants
www.PharmalinkConsulting.com
Quality System Consulting
ISO 9001:2000 Registered Quality Systems Consulting and Training
www.resultsinternational.net
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Medical Consulting
Ensure You Continue to Deliver Quality Results & Stay Compliant
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A-Z Pharmaceutical Quality Assurance Consulting Provider Directory
0-9 | A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Y | Z
A
Validation Systems, Inc.
Provides complete Validation and Laboratory Services to our clients.
members.aol.com
Automated Systems, Inc.
Wide range of abilities in pharmaceutical process, equipment and facilities engineering, automation, validation.
www.automatedsys.com
B
Beardsworth Consulting Group
Provider of clinical research management, data management, quality assurance and medical writing services to pharmaceutical, device and biotechnology companies throughout North America.
www.beardsworth.com
BioMetics, Inc.
Provides engineering, design, validation, cGMP consulting and project management services for biopharmaceutical and environmental technology companies
www.biometicsma.com
C
Columbia Pharma Consulting Services, Inc.
Provider of drug, OTC, medical device facility evaluations, QC/QA and bioequivalence laboratory operations, regulatory document preparation for therapeutic products, training programs, documentation systems and GMP, GCP and GLP monitoring servic...
www.columbiapharma.com
CRO Group
Contract organization for medical, biotechnology, and in vitro diagnostic device companies in CE Marking, design and development, clinical trials, QA, regulatory, reimbursement.
www.crogroup.com
D
Pharmaceutical Consultants
Provides services to the pharmaceutical and biopharmaceutical industries, regarding quality management and regulatory affairs.
www.david-begg-associates.com
Diversified Biomedical Technologies, Inc.
Provider of regulatory affairs and quality systems consulting services for clinical systems. Services are provided to multiple industries. This company was capitalized by private investment.
www.dbtco.com
Donawa and Associates
Offices in Italy and Ireland to assist medical device and in-vitro diagnostic companies in meeting US and European regulatory, clinical, technical and quality system requirements.
www.donawa.com
Drug & Device Development Co.
Services to help comply efficiently with FDA requirements.
www.druganddevice.com
E
Emergo Group, Inc.
ISO 9001 registered consulting firm with offices in the U.S. and Europe. Provides a full range of product compliance, quality assurance and export-related services and training for manufacturers and exporters of medical devices and in-vitro diag...
www.emergogroup.com
Excel Partnership
International training/consulting provider in business process improvement, ISO9000, QS-9000, TL9000, ISO14000, ISO Guide 25, Measurement and Calibration, Medical Device and other FDA Regulated industries.
www.excelpartnership.com
G
Global Validation Services
Provider of computer validation and systems assurance services for the pharmaceutical, biotechnology, medical device, nutritional, consumer products and cosmetics industries.
globalvalidation.com
Globpharm
Provides expert consulting services in the areas of GMP and Quality Systems to the worldwide pharmaceutical, biotechnology and medical device manufacturing industries.
www.globepharm.org
H
Validation Services
Quality / validation engineering and software services.
www.homestead.com
Honeyman Associates Pharmaceutical Purity Water Systems
Specialist consultancy based business, operating principally in the field of high purity water systems for the Pharmaceutical Industry.
www.honeyman.co.uk
I
International Pharmaceutical Services
Core competencies include business development, R&D management, information technolgy and regulatory affairs
www.intl-pharm-srv.com
International Regulatory Consultants
Specialize in helping manufacturers of medical products coordinate North American, European, and Pacific Rim regulatory affairs and quality systems compliance activities.
www.intregcon.com
Institute of Validation Technology
Provides educational publications, conferences and other informational products related to validation technology.
www.ivthome.com
K
Kmi-Parexel, Inc.
Provider of FDA compliance and validation services.
www.kminc.com
L
Lachman Consultants
Expert technical consultation in the areas of FDA Related Activities, Quality Control, Quality Assurance, Validation, Qualification, Stability and Expiration Dating.
www.lachmanconsultants.com
M
Maggid-Haffner Associates
Provider of quality assurance/quality control and regulatory affairs services.
www.magid-haffner.com
mdi Consultants
A FDA, IVDD, CE mark, HACCP, ISO9000, GMP, compliance consulting company for the medical device industry. Based in Great Neck, New York.
mdiconsultants.com
Medical Device & QA Consultancy
MDD 93/42/EEC "CE marking" consultancy, QA compliance and documentation review services.
www.mdqaconsultancy.co.uk
N
Noblitt & Rueland
FDA GMP, QSR, Design Control, software development, software validation, V&V, risk, hazard, submissions, 510(k), IDE, PMA, consulting and training.
www.noblitt-rueland.com
P
Perigon
Provider of engineering, architectural, project management and validation services to the process and pharmaceutical industries.
www.perigoneng.com
PharmaSys, Inc
Computer validation, equipment validation, process validation, thermal validation and FDA GMP compliance for the pharmaceutical, biotech and clinical trials industries.
www.pharma-sys.com
Pharmaceutical Services Corporation
A company specializing in validation, regulatory issues, compliance, calibration, and temporary laboratory services.
www.ps-corp.com
Pharmaceutical & Biotech Consulting
Provide professional consulting services applicable throughout the pharmaceutical, biotechnology and biologics product lifecycles.
www.PT-Resources.com
Q
Q-One
Provider of safety testing and process validation services, contract manufacturing of cell banks, vaccines and gene therapy products to the biopharmaceutical industry.
www.q-one.com
Quality & Compliance Consulting, Inc
Regulatory compliance issues, incorporating quality systems, and help assure validity and accuracy of regulatory submissions.
www.qc2.com
T
TechniPharm Consulting Group
Versatile engineering and scientific team with expertise in the pharmaceutical and biotechnology industries.
www.technipharm.com
Topaz Technologies
Based in Austin, Texas, provider of custom software, commercial software products, and consulting services for regulated markets.
www.topaztracks.com
William Trilsch & Associates
Quality Assurance and Regualtory Affairs consulting firm serving the biopharmaceutical industries.
www.trilsch.com
V
Validapro International
Specializes in validation and regulatory compliance.
www.validapro.com
Validation Associates, Inc.
Provides the pharmaceutical, biotechnology, and medical device industries with Computer System Validation Project Consulting and Training Services.
www.validassoc.com
Validation Technologies
Providing Worldwide Validation, Compliance and Technical Services to the Medical Device, Biotechnology and Pharmaceutical Industries.
www.validation.org
Validation Masters, Inc.
Customizes a validation program for a particular application, process or facility, providing an individual service or a fully integrated combination.
www.validationmasters.com
SBS Pharmaceutical Validation Services
Consulting services in pharmaceutical validation projects.
www.validationservices.co.uk
Schafer Veterinary Consultants
Worldwide consulting services to the veterinary pharmaceuticals and biologics industries. Based in Colorado.
www.verinet.com
Validation & Training Services, Inc.
Based in Massachusetts, provides software and process validation services.
www.vtsinc.net
W
Waldman Biomedical Consultancy Inc.
FDA compliance and regulatory support worldwide to manufacturers of biologicals, drugs and devices.
www.waldmanbiomed.com
Waldman Biomedical Consultancy
Complete FDA compliance and regulatory support worldwide to manufacturers of biologicals, drugs and devices.
www.waldmanbiomedical.com
The Weinberg Group
Helping businesses improve manufacturing processes, clear regulatory hurdles, defend products in courts and the media.
www.weinberggroup.com
QA Services
Proven QA expertise for any technology product.
www.provare.com
Pharmaceutical Consulting
Premier consulting firm serves the world's top 20 Pharma companies.
www.campbellalliance.com
ISO 9001 Certification
Fight the Recession w/Guaranteed Turnkey Solution & Mktg Assistance.
www.CMC-ChangeManagement.com

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Guide to Pharmaceutical Quality Assurance Consulting Education and Training

Broaden your professional expertise with pharmaceutical quality assurance consulting education and training

By Shannon Hurley


Whether you hope to or currently work at pharmaceutical quality assurance consultancies or pharmaceutical quality assurance consulting firms, taking part in additional educational and training programs will enhance your knowledge base and increase your competency as a consultant. Current and prospective clients will be at ease knowing you have taken the initiative to strengthen your background and continue your education.

Before deciding what course of action is appropriate for your pharmaceutical QA consultants goals and aspirations, consider the following regarding pharmaceutical quality assurance consulting education and training:

1. Participate in a training course to enhance your credentials working as a quality assurance in pharmaceutical industry consultant.

2. Participate in certificate program to increase your qualifications and ensure your desirability to pharmaceutical qa consulting companies.

3. Participate in validation and control programs of study to add to your pharma QA consulting background.

Action Steps
The best contacts and resources to help you get it done


Enroll in a training course to strengthen your qualifications working in pharma quality assurance co

Sign up for a pharmaceutical quality consulting related training course to refresh or add to your professional background. Many universities and colleges offer industry-specific courses that can be taken individually and not as part of a program. Taking one course at a time will allow you to continue your regular business schedule while adding to your skill set.

I recommend: Visit the Center for Professional Innovation & Education to learn about pharmaceutical quality assurance training courses. Learn about courses offered by the National Institute for Pharmaceutical Technology and Education at Purdue University.

Be desirable to pharma quality assurance consulting firms by completing a certificate program

Take part in a quality assurance pharmaceutical certificate program to broaden your professional expertise and make your resume more attractive to prospective clients. A certificate program will provide you with an in-depth and comprehensive understanding of QA pharmaceuticals that will enhance your pharmaceutical quality assurance consulting know-how and increase client leads.

I recommend: Check out the certificate courses available through the Office of Continuing Education-College of Pharmacy at the University of Florida. Take a look at the certificate programs offered by the Pharmaceutical Education & Research Institute.

Register for a validation and control program to increase your pharma QA consultants background

Participating in specialized industry-specific programs of study like those that focus on regulatory compliance and validation will be beneficial, as such topics are an important aspect of a consultant's expertise. Stay ahead of other pharmaceutical quality assurance consultants by keeping up-to-date with industry codes and regulations.

I recommend: View the Quality Assurance and Control program of study offered at the University of California, San Diego. Visit the Center for Professional Advancement website to learn more about pharmaceutical validation and regulatory compliance training programs.

FEATURED LISTINGS
Pharmaceutical & Biotech Consulting
Provide professional consulting services applicable throughout the pharmaceutical, biotechnology and biologics product lifecycles.
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Guide to Pharmaceutical Quality Assurance Consulting

Pharmaceutical QA consultants provide audit and quality assurance services to ensure product success

By Kristen McClung


Pharmaceutical quality assurance consultants are vital in developing pharmaceutical products that protect patient safety and ensure regulatory compliance. With their vast resources, pharmaceutical QA consultants use their experience, knowledge and skills to save you money, minimize your risk and facilitate your project speed.

Pharma quality assurance consulting firms help businesses achieve success in the design, execution and summary phases of clinical projects. To achieve the best product, quality assurance pharmaceutical consultants assist clients in navigating detailed inspections, approvals, regulations and guidelines.

Before beginning your search for pharmaceutical quality assurance consulting firms, it is important to define your needs. Clearly identify the goal of your pharmaceutical quality consulting service, including project scope, time frame and budget. This information will help you select the best QA pharmaceuticals consultant to meet your specific needs.

When selecting pharma QA consultants for your organization, research each consulting practice and evaluate the following:

1. How much experience do the pharmaceutical QA consulting companies have in developing quality products for your business sector?

2. What audit and regulatory services do the pharmaceutical quality assurance consultancies provide to ensure successful products?

3. How much should your business invest in pharmaceutical quality assurance consulting services?


Action Steps
The best contacts and resources to help you get it done


Hire pharmaceutical QA consultants who specialize in your business market

Select pharma QA consultants who are seasoned professionals with extensive experience in your business sector. Ask to see a list of past clients and request references.

I recommend: Campbell Alliance Group provides pharma QA consulting for pharmaceutical and biotech companies, contract research organizations (CROs), medical device and diagnostics companies, contract sales organizations (CSOs) and healthcare Information Technology clients. Pharmalink Consulting offers services for large corporations, biotechs, small start-ups, CROs and device manufacturers in the areas of biotech, consumer healthcare, pharmaceuticals, medical devices, clinical, nutraceuticals and veterinary. The CRO Group provides compliance and regulatory services for the biotech and medical device industries, and provides a partial online client list.

Choose quality assurance pharmaceutical firms with reputable skills

Review the consulting services offered by the pharma quality assurance consulting firms. Evaluate each firm's experience, qualifications and certifications, and request successful project examples.

I recommend: Phoenix Regulatory Associates provides application and submission services, Good Clinical Practice (GCP) audits, non-clinical program assessments, FDA post marketing reports, CMC section development and US FDA agent services for foreign clients. Validation Systems, Inc. offers validation and technical services, quality systems development and laboratory services. Automated Systems features a wide range of pharmaceutical consulting services, including quality systems and quality assurance.

Select pharmaceutical quality assurance consultants that meet your budget

Many pharmaceutical QA consulting companies operate on a retainer with a minimum time commitment. Several utilize a project-based or hourly fee structure for short-term projects. Your pharma QA consulting cost will depend upon the scope of your services.

I recommend: Request a quote for QA audit services at Beardsworth Consulting Group, a full-service contract research organization. Submit a cost proposal inquiry for pharmaceutical QA consulting services at Diversified Biomedical Technologies.

Tips & Tactics

Helpful advice for making the most of this Guide

  • •  Make sure that it is written into your contract that the QA pharmaceuticals consulting firm will not provide services to any competing company or product during the course of your business relationship.
  • •  Before signing a contract, make sure your pharma quality assurance consulting firm has an excellent reputation in the regulatory and clinical community, as well as positive relationships with the various divisions of the FDA.

FEATURED LISTINGS
Pharmaceutical & Biotech Consulting
Provide professional consulting services applicable throughout the pharmaceutical, biotechnology and biologics product lifecycles.
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Guide to Pharmaceutical Quality Assurance Consulting Key Terms

Learn the key terms related to pharmaceutical quality assurance consulting

By Jessica Riendeau


Pharmaceutical quality assurance consulting is a vital part of the healthcare industry, ensuring that hospitals, pharmacies, and healthcare facilities like nursing homes and rehabilitation centers operate at the highest standard of quality and patient care.

Pharmaceutical consulting is accompanied by a lot of jargon that is specific to the healthcare industry. It's important to understand key terms related to pharmaceutical quality assurance consulting to guarantee that your healthcare business is operating according to safety, sanitation and quality standards.


Action Steps
The best contacts and resources to help you get it done


Accreditation

Accreditation is an evaluation process conducted by a certified accreditor that inspects hospitals, pharmacies and other healthcare facilities. The accreditor gives approval once assured that the facility is complying with all state and federal regulations and delivering the highest quality of patient care and support.

I recommend: ISQua explains what health care accreditation entails and the process by which healthcare facilities are evaluated.

Ordered recall

An ordered recall is an action taken by the Food and Drug Administration (FDA) when a prescription medication is found to be unsafe due to manufacturer defect or continuing research into possible side effects and interactions. The product is taken off the market and no longer prescribed.

I recommend: Dialog explains the three classes of an ordered recall and the steps taken by the FDA to issue an ordered recall.

Market withdrawal

A market withdrawal occurs when the FDA notifies every manufacturer of a specific product that there are safety concerns with unknown origins, resulting in a market-wide withdrawal of the food or drug in question.

I recommend: Read more about the market withdrawal policies set by the U.S Food and Drug Administration.

Good manufacturing practices

Good manufacturing practices, or GMP, are the federal healthcare standards set for quality control in storage, acquisition, dispensing and patient care related to medications, healthcare and medical devices.

I recommend: The GMP Institute offers more information on GMP regulations.

Active pharmaceutical ingredients

Active pharmaceutical ingredients are the chemical components of a medication that have an affect on the body. Other chemical components, often referred to as binders, work to hold the active ingredients together cohesively but do not have an active impact on the body's systems.

I recommend: DrugDevelopment-Technology.com defines active pharmaceutical ingredients and provides resources to learn more about their applications.

Clinical trial monitoring

Clinical trial monitoring is a quality control system used to ensure quality and accuracy of the trials conducted to determine effectiveness of medications or medical devices. Clinical trial monitoring ensures that standards of quality are followed during testing and that results and data are reported accurately and indiscriminately.

I recommend: The National Institute of Allergy and Infectious Diseases explains the purpose of clinical trial monitoring and how monitoring is conducted. Read more about the standards for safety and monitoring and the different regulations for human test subjects.

FEATURED LISTINGS
Pharmaceutical & Biotech Consulting
Provide professional consulting services applicable throughout the pharmaceutical, biotechnology and biologics product lifecycles.
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Pharmaceutical Quality Assurance Consulting Education and Training

Broaden your professional expertise with pharmaceutical quality assurance consulting education and training.
Whether you hope to or currently work at pharmaceutical quality assurance consultancies or pharmaceutical quality assurance consulting firms, taking part in additional educational and training programs will enhance your knowledge base and increase your competency as a consultant. Current and prospective clients will be at ease knowing you have taken the initiative to strengthen your background and continue your education.Before ... Read more
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