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GMP Compliance

    
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Compliance Insight, Inc.  Specializing in hands-on FDA Regulatory and Quality Assurance consulting and training for pharmaceutical, medical device, clinical operations and biotechnology industries worldwide.
 
GMP-GCP Training Training is more than just sitting down with people to read SOP’s. While instruction is important, teaching should go beyond a specific function. Our goal...
 
Services At Compliance Insight, it is our belief that a pro-active solution works best. This sets the stage for long-term success. Our thorough evaluation...
cGMP Validation  cGMP Validation provides full service Validation and GMP Compliance consulting services for the pharmaceutical, biotech, medical device, and medical diagnostic industries. cGMP Validation specializes in the preparation...
RegCom Consultant Inc.  RegCom Consultant Inc. is a global management consulting firm. Our services are Regulatory registration, GMP Compliance, Licence registration, Project Management, Pharmacovigilance
GMP Learning  Since 1993 GMP Learning has been working and helping companies improve individual competency, job performance and meet regulatory compliance requirements regarding employee/associate qualifications. Results impact the...
 
GMP Consulting Services GMP Learning has been working and helping companies improve individual competency, job performance and meet regulatory compliance requirements regarding...
Keller Consulting  Since 1998, Keller Consulting has assisted large and small scale companies globally meet their regulatory requirements. We have assisted companies in the pharmaceutical, OTC, API, cosmetic, health and beauty and natural...
 
Pharmaceutical Consultant - Assistance with manufacturing and product transfer - Assistance with API requirements - **NEW** Assistance with formulation and process development - GMP...
cGMP Validation, LLC  cGMP Validation, LLC is a significant provider of validation and compliance support consulting to the pharmaceutical, biologicals, biotechnology, therapeutics, and medical devices industries. For over 12 years, we have...
Compliance Net, Inc.  ComplianceNet, Inc. provides a wide variety of services to help companies meet international regulatory challenges. Consultants specialize in guiding small, start-up firms to establish efficient, cost effective and...
 
GMP Consulting Services ComplianceNet specializes in helping small, start up pharmaceutical firms establish efficient, cost effective quality systems that will pass inspection and...
ClinAudits, LLC  ClinAudits is an independent, 3rd party, niche provider of GXP (GCP, GMP, GLP, GTP) compliance, auditing and consulting services for the pharmaceutical, medical device, biotechnology and tissue engineering industries. ...
 
Good Manufacturing Practices (GMP) Service Offerings It includes GMP – GMP facility audit to FDA requirements GTP – Tissue engineering, cell therapy and tissue bank audits Internal audit system development.
RD Laboratories  R. D. Laboratories, Inc. is a full service contract testing laboratory, specializing in pharmaceutical analysis. Since our founding in 1984, we have continued to provide analytical testing and full-service technical...
ComplianceLogix  ComplianceLogix provides quality assurance and regulatory compliance consulting services for the biopharmaceutical industry. Services include GCP Training, GLP Training, GMP Training, and Quality Assurance Audits.
 
Auditing Quality Assurance Audit
 
 
CALISO Consulting, Inc.  CALISO is a privately held corporation, originally created in 1996 to help organizations and companies comply with quality, environmental, and safety STANDARDS AND REGULATION. Our consulting and training services are...
 
FDA 510(k) Approval, FDA Approval, 510K For medical devices classified as Class II or Class III, a 510K approval is necessary in order to market the product in the US. The approval requires...
 
MDD CALISO offers professional consulting for medical device manufacturers, including services geared towards 510k approval and CE certification requirements....
Wadjet Consulting Inc.  Located in Ajax Ontario, Wadjet Consulting Inc. was founded in 2003 as a consulting firm providing comprehensive quality assurance and compliance management services to Health Canada-regulated Firms. Our Consultants have...
 
Compliance Wadjet Consulting Inc. ensures that your company is familiar with the Canadian Regulatory changes and challenges, covering natural health products, medical...
Quadscience  Quadrants Scientific Incorporated is dedicated to the delivery of high quality, cost effective, prompt technical support services to the FDA regulated industries. Support is provided as "state-of-the-art" analytical...
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More

GMP Compliance Research Library

Process Validation:  Understanding FDA's guidance and what it means for your company
Compliance Insight, Inc.
5850 Boymel Drive, Suite 1 Fairfield, OH 45039 Tel.: 513.860.3512 Fax: 513.860.3406 www.compliance-insight.com Written by: Michael Goodman Compliance Insight, Inc. A sponsored Process Validation Q &A Understanding FDA’s guidance and what it discussion means for your company The new guidance updates FDA’s original 1987 think- ing on process validation in Current Good Manufacturing ...
 
Keys to Implementing a Successful Compliance Training Program
ComplianceLogix
Keys to Implementing a Successful Compliance Training Program The expectation of any company is to provide training for their employees in order to perform their required functions. This sounds easy but in reality it can be difficult to accomplish. Companies are generally under-resourced to adequately prepare training courses and course assessments to ensure that employees have learned the ...
 
Invensys Process Systems Document
Invensys Operations Management
The Invensys Operations Management (IOM) Regulatory Compliance team of dedicated industry experts is focused on providing you with strict regulatory adherence in a timely and cost effective manner. This includes comprehensive regulatory compliance and validation services that are focused on but not limited to, environmental monitoring systems, building management systems, manufacturing, ...
 
Auditing the Viral Clearance Testing Laboratory
Compliance Insight, Inc.
5850 Boymel Drive, Suite 1 Fairfield, OH 45039 Tel.: 513.860.3512 Fax: 513.860.3406 www.compliance-insight.com AUDITING THE VIRAL CLEARANCE TESTING LABORATORY Written by: Jeri Ann Boose, Ph.D., and Michelle Arvoy Compliance Insight, Inc. This paper outlines the key elements that should be evaluated during a pre-qualification viral clearance audit. Development of this outline was based upon ...
 
Establishing Target Fill Counts for Solid Oral Dosage Forms
Compliance Insight, Inc.
5850 Boymel Drive, Suite 1 Fairfield, OH 45014 Tel.: 513.860.3512 Fax: 513.860.3406 www.compliance-insight.com Establishing Target Fill Counts for Solid Oral Dosage Forms Written by: Troy Fugate, Vice President Compliance Insight, Inc. Any pharmaceutical firm has the capability to package a variety of solid dose products into bottles. The question being addressed by this paper is the ...
 

GMP Compliance Video

GAGEtrak - Features CyberMetrics Corporation GAGEtrak calibration management is a feature-rich and easy-to-use software solution that will meet the needs of virtually any organization. Features ...
 
GAGEtrak - Measurement Systems Analysis CyberMetrics Corporation GAGEtrak Calibration Management Software - MSA Suite - Introductory Video - CyberMetrics Corporation
 
GMP Compliance EMD Millipore Bioscience Company

GMP Compliance News

GMP Compliance Wockhardt Pharmaceuticals
GMP Compliance Union Standard Equipment Information
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