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Manage and Measure Batch Record, Change Control and Event Reviews
Experience developing & launching over 400 products. NDA, ANDA, OTC
Premier consulting firm serves the world's top 20 Pharma companies.
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Pharmaceutical Quality Assurance Consulting
Pharmaceutical QA consultants provide audit and quality assurance services to ensure product successBy 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?
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.
Try:
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.
Try:
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.
Try:
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.
- 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.
Manage and Measure Batch Record, Change Control and Event Reviews
Experience developing & launching over 400 products. NDA, ANDA, OTC
Premier consulting firm serves the world's top 20 Pharma companies.
Wide range of abilities in pharmaceutical process, equipment and facilities engineering, automation, validation.
Provider of clinical research management, data management, quality assurance and medical writing services to pharmaceutical, device and biotechnology companies throughout North America.
Provides engineering, design, validation, cGMP consulting and project management services for biopharmaceutical and environmental technology companies
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 services. Servi
http://www.columbiapharma.com/
Contract organization for medical, biotechnology, and in vitro diagnostic device companies in CE Marking, design and development, clinical trials, QA, regulatory, reimbursement.
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.
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.
Services to help comply efficiently with FDA requirements.
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 diagnostics.
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.
http://www.excelpartnership.com/
Provider of computer validation and systems assurance services for the pharmaceutical, biotechnology, medical device, nutritional, consumer products and cosmetics industries.
Provides expert consulting services in the areas of GMP and Quality Systems to the worldwide pharmaceutical, biotechnology and medical device manufacturing industries.
Honeyman Associates Pharmaceutical Purity Water Systems
Specialist consultancy based business, operating principally in the field of high purity water systems for the Pharmaceutical Industry.
Institute of Validation Technology
Provides educational publications, conferences and other informational products related to validation technology.
International Pharmaceutical Services
Core competencies include business development, R&D management, information technolgy and regulatory affairs
http://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.
Expert technical consultation in the areas of FDA Related Activities, Quality Control, Quality Assurance, Validation, Qualification, Stability and Expiration Dating.
http://www.lachmanconsultants.com/
Provider of quality assurance/quality control and regulatory affairs services.
A FDA, IVDD, CE mark, HACCP, ISO9000, GMP, compliance consulting company for the medical device industry. Based in Great Neck, New York.
Medical Device & QA Consultancy
MDD 93/42/EEC "CE marking" consultancy, QA compliance and documentation review services.
http://www.mdqaconsultancy.co.uk/summary.html
FDA GMP, QSR, Design Control, software development, software validation, V&V, risk, hazard, submissions, 510(k), IDE, PMA, consulting and training.
http://www.noblitt-rueland.com/
Provider of engineering, architectural, project management and validation services to the process and pharmaceutical industries.
Provides services to the pharmaceutical and biopharmaceutical industries, regarding quality management and regulatory affairs.
http://www.david-begg-associates.com/
Pharmaceutical Services Corporation
A company specializing in validation, regulatory issues, compliance, calibration, and temporary laboratory services.
Computer validation, equipment validation, process validation, thermal validation and FDA GMP compliance for the pharmaceutical, biotech and clinical trials industries.
Provider of safety testing and process validation services, contract manufacturing of cell banks, vaccines and gene therapy products to the biopharmaceutical industry.
Quality & Compliance Consulting, Inc
Regulatory compliance issues, incorporating quality systems, and help assure validity and accuracy of regulatory submissions.
SBS Pharmaceutical Validation Services
Consulting services in pharmaceutical validation projects.
http://www.validationservices.co.uk/
Schafer Veterinary Consultants
Worldwide consulting services to the veterinary pharmaceuticals and biologics industries. Based in Colorado.
http://www.verinet.com/schafer/
Versatile engineering and scientific team with expertise in the pharmaceutical and biotechnology industries.
Helping businesses improve manufacturing processes, clear regulatory hurdles, defend products in courts and the media.
Based in Austin, Texas, provider of custom software, commercial software products, and consulting services for regulated markets.
Specializes in validation and regulatory compliance.
Validation & Training Services, Inc.
Based in Massachusetts, provides software and process validation services.
Provides the pharmaceutical, biotechnology, and medical device industries with Computer System Validation Project Consulting and Training Services.
Customizes a validation program for a particular application, process or facility, providing an individual service or a fully integrated combination.
http://www.validationmasters.com/
Provides complete Validation and Laboratory Services to our clients.
http://members.aol.com/vsiserve/
Providing Worldwide Validation, Compliance and Technical Services to the Medical Device, Biotechnology and Pharmaceutical Industries.
Waldman Biomedical Consultancy
Complete FDA compliance and regulatory support worldwide to manufacturers of biologicals, drugs and devices.
http://www.waldmanbiomedical.com/
Waldman Biomedical Consultancy Inc.
FDA compliance and regulatory support worldwide to manufacturers of biologicals, drugs and devices.
Quality Assurance and Regualtory Affairs consulting firm serving the biopharmaceutical industries.
Tips & Advice to help you make your decision on Pharmaceutical Quality Assurance Consulting
Pharmaceutical quality assurance consulting is an essential component to the structure of a business which deals in drug distribution. Pharmacies carry sensitive medications which must be handled with care. Giving the wrong medication to a client can result in severe legal implications and business failure. Having a contracted consultant can help you establish relations with suppliers and develop systems for storage and distribution which reduces the risk of such incidents.
There are various consulting agencies to choose from offering services that assist in inspections, approvals and the navigation of regulatory standards. Having this type of support can help to build a ... more
Pharmaceutical quality assurance consulting is an essential component to the structure of a business which deals in drug distribution. Pharmacies carry sensitive medications which must be handled with care. Giving the wrong medication to a client can result in severe legal implications and business failure. Having a contracted consultant can help you establish relations with suppliers and develop systems for storage and distribution which reduces the risk of such incidents.
There are various consulting agencies to choose from offering services that assist in inspections, approvals and the navigation of regulatory standards. Having this type of support can help to build a pharmaceutical business and allows for confidence in daily operations. They streamline the business development process to get your establishment off the ground while minimizing risk and expenditures.
To find an agency that can assist your business there are many resources. Take into consideration the needs of your company and how a consultant may address them. Evaluating the reputation of several companies and reviewing terms of contracts available to you will allow you to make an informed choice. For businesses looking for pharmaceutical quality assurance consulting services try clicking the links to the left for further information and available agencies.