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Most Recent Regulatory Expert Exchange Submissions
Oxidative Stress Assessment at Kronos Science Laboratory - Oxidative Stress Assessment at Kronos Science Laboratory by Christopher B. Heward, Ph.D. and Yali Su, Ph.D. In recent years, research evidence has been accumulating that damage to cell components (proteins, cell membrane lipids, and the DNA of both chromosomes and mitochondria) by oxygen free radicals (also known as
Oxidative Stress Assessment at Kronos Science Laboratory
Extensional Rheometry - CPG has expertise in extensional rheometry, which is the study of fluid flow in an extensional, rather than shear, deformation. The bulk of material processing involves a combination of shear and extension, and the flow resistance of polymeric materials can change dramatically with extensional deformation. This article summarizes a simple approach for extensional rheometric characterization. read more...
Extensional Rheometry
Bringing medicinal products to market in The European Union (EU) - Bringing Medicinal Products to the European Union Market By Dr. Jan van der Weide Pharmalink Consulting Ltd. Introduction to the European Union The European Union (EU) is a supranational and intergovernmental union of twenty-seven states in a category of its own. It was established in 1992 by the Treaty on European Union (The Maastricht Treaty), and is the de facto successor to the six-member European Economic Community founded in 1957. Since then new accessions have raised its number of read more...
Bringing medicinal products to market in The European Union (EU)
HERBAL MEDICINAL PRODUCTS: Quality, Safety and Efficacy considerations - HERBAL MEDICINAL PRODUCTS: Quality, Safety and Efficacy considerations Dr Jung Wing Wan, Pharmalink Consulting Inc. Dr Jung Wing Wan of Pharmalink Consulting Ltd ponders the quality, safety and efficacy considerations of herbal products, and examines the development of regulations inside and outside Europe. Information about the author. Dr Jung Wing Wan is currently a regulatory project manager for Pharmalink Consulting Inc., having worked on a number of European regulatory projects wi read more...
HERBAL MEDICINAL PRODUCTS: Quality, Safety and Efficacy considerations
"Future Trends of the GMP's in Japan - based on ICH Guidelines and related activities",
A Practical Guide to Applying Impact and Risk Concepts to - INTRODUCTION In recent years, the Food and Drug Administration (FDA)-regulated industry has been listening to agency representatives and consultants talking about the need to implement a risk-based approach to decision-making processes. I totally agree with the need to implement this
A Practical Guide to Applying Impact and Risk Concepts to
RECENT FDA AND INTERNATIONAL REGULATORY EFFORTS AFFECTING FACILITY AND UTILITY SYSTEMS DESIGN AND QUALIFICATION - Introduction It is clearly recognized that the use of adequate facilities and utility systems has a critical effect on our capacity to produce products, which will consistently meet the pre-defined specifications. The adequate design of such facilities and ancillary systems is vital to the overall success of any manufacturing process/operation. The harmonization of the compliance requirements established by regulatory agencies around our global industry is an on-going reality. It will read more...
RECENT FDA AND INTERNATIONAL REGULATORY EFFORTS AFFECTING FACILITY AND UTILITY SYSTEMS DESIGN AND QUALIFICATION
Top 10 Tips for Safely Handling and Using Gas Cylinders - Not every one needs to know that fluorine will violently ignite many substances, that silane burns on contact with air, or that ammonia will decompose thermally into twice its volume. But if you work with specialty gases, this information is essential. Safety must always be a primary goal when working with specialty gases -safety and knowledge go hand-in-hand. To improve your chances of preventing hazardous accidents, follow these Top 10 Tips for safely handling and using gas cylinders: read more...
Top 10 Tips for Safely Handling and Using Gas Cylinders
Concordance of MBL Protein Concentrations, Functional Activities and Genotypes in a Healthy Control Population - http://www.ibtreflab.com/library/PDF/2005AAAAIPosterMBL.PDF read more...
Concordance of MBL Protein Concentrations, Functional Activities and Genotypes in a Healthy Control Population
Abstract Presented at the 5th Meeting of the European Society for Chlamydial Research - http://www.ibtreflab.com/library/PDF/EuropeanCPNConference2004.PDF read more...
Abstract Presented at the 5th Meeting of the European Society for Chlamydial Research
Are Chlamydia pneumoniae and Mycoplasma pneumoniae Important Etiological Agents of Respiratory Tract Infection in a Family Practice Setting? - http://www.ibtreflab.com/library/PDF/2004AAAAIPoster.PDF read more...
Are Chlamydia pneumoniae and Mycoplasma pneumoniae Important Etiological Agents of Respiratory Tract Infection in a Family Practice Setting?
Preventing specimen degradation - Many clinical samples can deteriorate during shipment and storage, due to storage at improper time and temperature. CliniSense is introducing a new electronic chip technology, called the
Preventing specimen degradation
New Approaches for Assessing Conditioning and Quantifying Silicone Deposition on Hair - In this technical paper, Dow Corning scientists present results from deposition evaluations and analytical studies that show promise for the creation of hair care products. read more...
New Approaches for Assessing Conditioning and Quantifying Silicone Deposition on Hair
An Analytical Method for Adsorbed Soil Gas Hydrocarbons (SGH) to Depict Anomaly Patterns over Various Types of Deeply Buried Deposits - Geochemical Actlabs & Geosoft (915 KB) Interactive Demo - Integrating Exploration Geochemistry Application Data A
An Analytical Method for Adsorbed Soil Gas Hydrocarbons (SGH) to Depict Anomaly Patterns over Various Types of Deeply Buried Deposits
STERILITY AND FUNDAMENTAL REQUIREMENTS OF STERILE PRODUCTS - What is sterility? Sterility is the total absence of pathogens in a finished sterile product. Sterile products include: parenterals (injectables), ophthalmics, inhalation aerosols, and their administration devices. One of the first steps in manufacturing a sterile product is the use of rigid aseptic procedures in a well designed controlled clean room environment. Clean rooms are constructed, and maintained to prevent environmental contamination during manufacture.  Includes: o smoo read more...
STERILITY AND FUNDAMENTAL REQUIREMENTS OF STERILE PRODUCTS
LTQ FT MS Review - JCL Bioassay, Inc. has recently purchased LTQ FT MS by Thermo Electron Corporation. This system can assist in toughest analytical challenges in metabolic studies, proteome analysis, pharmaceutical discovery, and all other applications demanding rigorous structural characterization. For more information, please contact 847-866-0410. read more...
LTQ FT MS Review
Solving the Universal Vulnerability and Liability Problems - NOVA WHITE PAPERS Solving the Universal Vulnerability and Liability Problems of Public Water Systems Paul J. Pearce, PhD Dear Reader: In the homeland security era, public water systems face an entirely new set of vulnerability and liability problems. A new class of services and products may be the solution to these problems. In compliance with the Bioterrorism Act of 2002 (Public Law 107-188), many public water systems have completed their vulnerability assessments (VAs). A read more...
Solving the Universal Vulnerability and Liability Problems
Quality Organizations Provide for a Unique Learning Experience - By Farrah N. Khan, CQA, RQAP-GLP Northview Pacific Laboratories' Quality Assurance Department is taking an active role with several quality organizations. New systems, processes and ideas are always being introduced in the world of quality and it isn't an easy task to keep on top of all of them. One way that Northview keeps on track is to stress the importance of continued education. Our QA staff are not only members, but active participants in quality organizations such as: American Socie read more...
Quality Organizations Provide for a Unique Learning Experience
Supplement 8 of USP 23 Serves As A Guide For Establishing A Microbial Monitoring Program - At BEC Labs, we are often asked to help customers define environmental sampling plans for their manufacturing facilities. In doing so, we now refer them to Supplement 8 of USP 23, Section 1116, Microbiological Evaluation of Clean Rooms and Other Controlled Environments. Following is a summary of the informational chapter, which addresses how to establish, maintain, and control the microbiological quality of a controlled environment. Cleanrooms have traditionally been classified using air clea read more...
Supplement 8 of USP 23 Serves As A Guide For Establishing A Microbial Monitoring Program
Method Development & Validation - A pharmaceutical company required a full set of validated analytical procedures in order to proceed through clinical trials towards FDA approval. Chemir Analytical Services developed and validated chromatographic methods to assess the quality of the materials, including determination of physical properties and levels of impurities. The detailed report was satisfactory for FDA review. read more...
Method Development & Validation
New-age Paint Thickening & Rheological Additives : Solvitex & Solvizen - For Paint Manufacturers worldwide, there has come a radical new development in the legion of Thickening Agents & Colloidal stabilizer for Aqueous Latex Paints. So far most of the companies producing aqueous Paint emulsions, the most preferred thickening agent was Hydroxy ethyl cellulose (HEC). The HEC based thixotropic additives is produced by some of the renowned multi-national companies such as Hercules, Akzo Nobel & Dow. Here we refer to a Biopolymer based on Polysacchride derived from co read more...
New-age Paint Thickening & Rheological Additives : Solvitex & Solvizen
Using Contract Services Wisely: - Contract services are a means to boost your productivity and capabilities without adding permanent capabilities. Finding the right outsourcing partner should reward you with a strategic alliance for your business. Finding the wrong partner will slow your progress and prevent you from reaching your potential. A couple of simple questions will move you on your way to finding a laboratory that supplements your efforts to develop a product, maintain quality, understand the chemistry, or accelera read more...
Using Contract Services Wisely:
Contract Pharma Annual Meeting Review - The 2nd Contract Pharma Annual Meeting, sponsored by Contract Pharma Magazine was held Sept. 25-26 in Edison, NJ. Attendance improved over the first year with more industry professionals participating in a series of seminars and an exhibit hall. The focus of the show was weighted more heavily towards the business and operations environment. Less emphasis was placed on science and technology applications, which are typically more at home at DIA, CRS, ISPE and AAPS. The show and the contract i read more...
Contract Pharma Annual Meeting Review
Labeling of Laboratory Solutions - In order to maintain GMP compliance (Good Manufacturing Practices, 21CFR211), ensure that all solutions prepared in your lab are labeled with the the prep date, expiration date, initials of the person preparing the solution, the identity of the solution and the concentration. You will be the guaranteed recipient of an observation (which may land on a 483!) during a regulatory or customer inspection of your lab if improperly labeled solutions are observed. To learn more about lab audit service read more...
Labeling of Laboratory Solutions
Improving your Lab Resume - Join a Professional Organization. . Joining a professional organization shows that you have interest in staying current with what's going on in your industry. List the professional organizations that you belong to on your resume. 2 - Add detailed descriptions of types of testing and techniques that you have used and are familiar with. 3 - Modify your resume to fit the job description that you are applying for. Highlight the areas in your career development that meet each requirement of the read more...
Improving your Lab Resume
Auditing - 1 - Audit all contract laboratories that perform testing for your company. You are responsible for all of the work that your contract laboratories perform for you. It is very important to audit labs that are listed in product submissions to the FDA as the FDA may inspect those labs in the process of approving your product. If you are not confident in your auditing skills, ContractLaboratory.com provides 3rd party laboratory audit services. Contact us at admin@ContractLaboratory.com for more info read more...
Auditing
Writing SOPs - Make sure that SOPs are written by knowledgeable personnel and clearly describe all steps in a manner that is easy to understand. If you need help writing operating procedures for your lab you may submit a project request on the ContractLaboratory.com 'Outsource' project page, or check the 'Events' page for an SOP writing workshop that you may want to attend. read more...
Writing SOPs
Laboratory Data Errors and Corrections - If your lab, or your customers' samples, are regulated by the Food and Drug Administration (FDA), do not obscure or erase original laboratory data entries when making corrections. Instead, place one single line through the incorrect information, write the new information, date the correction, and initial or sign your name by the correction. You must also provide an explanation for why the correction was necessary. The explanation will make it easier for you to remember and describe the actual s read more...
Laboratory Data Errors and Corrections
Recording of Laboratory Data - If your laboratory, or your customers' samples, are regulated by the Food and Drug Administration (FDA), document all data entries with indelible ink. Other inks will run or smear if documentation gets wet (easy to accomplish in the lab!) and your data will be obscured. Clear and readable data entries are very important. If your lab needs training on documentation practices, or a documentation audit performed, ContractLaboratory.com offers laboratory audit services and on-line consulting to read more...
Recording of Laboratory Data
Passwords for Computerized Instruments - If your firm is regulated by the FDA, develop an operating procedure (SOP) for assigning, changing, and choosing passwords for computer systems. Check the computer validation guidelines available at www.FDA.gov for information on controlling entry to and use of computerized instruments. read more...
Passwords for Computerized Instruments
Quality Agreements and Quality Contracts - If your firm is regulated by the FDA, develop Quality Agreements or Quality Contracts with your contract laboratories. read more...
Quality Agreements and Quality Contracts
URINARY EXCRETION OF THREE NUCLEIC ACID OXIDATION ADDUCTS AND ISOPROSTANE F2a MEASURED BY LIQUID CHROMATOGRAPHY MASS SPECTROMETRY IN SMOKERS, EX-SMOKERS, AND NONSMOKERS - Abstract-Quantification of 8-iso-prostaglandin F2a (8-iso-PGF2a) has been suggested to be a reliable indicator of lipid peroxidation that may be related to in vivo free radical generation, oxidative damage, and antioxidant deficiency. We have developed a LC-MS/MS method to quantify 8-iso- PGF2a and its dinor metabolite, 2,3-dinor-8-iso-prostaglandin F2a (2,3-dinor-8-iso-PGF2a), in human urine samples. After an initial purification step using an automated C18 solid phase extraction procedure, the read more...
URINARY EXCRETION OF THREE NUCLEIC ACID OXIDATION ADDUCTS AND ISOPROSTANE F2a MEASURED BY LIQUID CHROMATOGRAPHY MASS SPECTROMETRY IN SMOKERS, EX-SMOKERS, AND NONSMOKERS
Polymer Materials Selection for Radiation-Sterilized Products - Choosing the right polymer for a radiation-sterilized device requires an understanding of radiation effects, manufacturing processes, and the product's intended use. read more...
Polymer Materials Selection for Radiation-Sterilized Products
- read more...
Laboratory Notebooks - For compliance to FDA, instruct all lab technicians not to tear pages out of their notebooks. read more...
Laboratory Notebooks
FDA Inspections - If the FDA comes for an inspection, make sure you are shown their credentials. read more...
FDA Inspections
Selecting a Contract Laboratory - For critical testing, audit a lab prior to selecting a contract laboratory. read more...
Selecting a Contract Laboratory
Effective Use of Contract Laboratories - To best use contract laboratories, appoint one person in your company as the firm contact read more...
Effective Use of Contract Laboratories
Cosmetics & Toiletries - Global Outsourcing & Private Label Manufacturing - After recent globalization and change in policies the opportunities for manufacturers & exporters have widen. Today we can say that the producers are coming-off their age from traditional methods. The developments are becoming trend setting. The Manufacturers are versatile to cope up with the vibrant consumer behavior. The globalization in terms of foreign trends & acceptability has penetrated finely into the Indian buying market and so is the Local manufacturer's struggle to captivate the o read more...
Cosmetics & Toiletries - Global Outsourcing & Private Label Manufacturing
Kronos Science Laboratory Fatty Acid Poster - Kronos Science Laboratory Fatty Acid Poster http://www.contractlaboratory.com/www/labuploads/Kronos_ Fatty_Acid_Poster.pdf read more...
Kronos Science Laboratory Fatty Acid Poster
REGULATORY JOBS
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Senior Program Officer, Quality Assurance and Regulatory, Vaccine Development
Regulatory Job Listing Company or Recruiter: Sabin Vaccine Institute
Sr. Regulatory Affairs Specialist / Manager
Regulatory Job Listing Company or Recruiter: Gen-Probe Incorporated
Research and Regulatory Manager
Regulatory Job Listing Company or Recruiter: Harvard School of Public Health
Regulatory Affairs Associate
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Research and Regulatory Manager
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Demonstrate your regulatory knowledge and share regulatory resources in our Regulatory Exchanges. Resources such as Tips, Case Studies, Articles, Reviews, Questions and Answers, Podcasts, Checklists, Templates, Procedures, Presentations, Posters, Images,etc are now being accepted! All submissions must be relevant to regulated industries such as pharmaceuticals, biotechnology, biopharmaceuticals, healthcare

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International Regulatory News

FDA seeks $4.5 billion to support medical product development, protect patients and ensure safety of the food supply
2012-02-22 00:00:00
FY 2013 request reflects a 17 percent increase from FY 2012 budget The U.S. Food and Drug Administration is requesting a budget of $4.5 billion to protect and promote the public health as part of the President's fiscal year (FY) 2013 budget - a 17... 

FDA seeks $4.5 billion to support medical product development, protect patients and ensure safety of the food supply
2012-02-13 00:00:00
FY 2013 request reflects a 17 percent increase from FY 2012 budget The U.S. Food and Drug Administration is requesting a budget of $4.5 billion to protect and promote the public health as part of the President's fiscal year (FY) 2013 budget - a 17... 

FDA issues draft guidance on biosimilar product development
2012-02-09 00:00:00
For Immediate Release: Feb. 9, 2012 Media Inquiries: Sandy Walsh, 301-796-4669; sandy.walsh@fda.hhs.gov Consumer Inquiries: 888-INFO-FDA The U.S. Food and Drug Administration today issued three draft guidance documents on biosimilar product... 

FDA completes work on three drug user fee programs
2012-01-31 00:00:00
The U.S. Food and Drug Administration has completed its recommendations for three user fee programs that will help speed safe and effective drugs and lower-cost generic drug and biosimilar biological products to patients, FDA Commissioner Margaret A.... 

Department of Justice files consent decree of permanent injunction against Ranbaxy
2012-01-25 00:00:00
Generic drug manufacturer agrees to remedy deviations from the current good manufacturing practice requirements and to correct data integrity problems at numerous facilities The Department of Justice, on behalf of the U.S. Food and Drug Administra... 

FDA to protect important class of antimicrobial drugs for treating human illness
2012-01-04 00:00:00
The U.S. Food and Drug Administration today issued an order that prohibits certain uses of the cephalosporin class of antimicrobial drugs in cattle, swine, chickens and turkeys effective April 5, 2012. Antimicrobial drugs are important for treati... 

FDA proposes draft guidelines intended to improve the representation of women in medical device clinical studies
2011-12-16 00:00:00
Draft guidance aimed to address the historic underrepresentation of women in clinical studies was issued by the U.S. Food and Drug Administration today. Intended for medical device developers and manufacturers, the guidance outlines agency recommenda... 

Trident catheter valve - Model Number: 380851
2011-12-12 00:00:00
The Therapeutic Goods Administration (TGA) advises that certain lots of the Trident Catheter Valve (Australian Register of Therapeutic Goods (ARTG) number 107139) are being recalled. The Trident Catheter Valve is used for connecting a urinary cath... 

UKAS Assessment Programme for Accreditation for Certification of Green Deal Advisors and Installers
2011-12-12 00:00:00
The deadline for applications to participate in the UKAS programme for the accreditation of certification bodies to certify Green Deal Advisors and Installers expired on 30 September 2011. UKAS received 33 applications from organisations who wish to ... 

TGA reforms: a blueprint for TGA's future
2011-12-08 00:00:00
Government to improve regulation of therapeutic goods media release, The Hon Catherine King MP 8 December 2011 The Australian Government has released its response to several major reviews of therapeutic goods regulation that have been undert... 

Respirtek ISO 17025 Business Management Improvements
2011-11-22 00:00:00
After 10 years of diverse bioenvironmental research and testing, RespirTek has obtained ISO 17025 Certification and is continuing to improve upon the strong foundations of excellent customer service and quality testing that has served our clients wel... 

Respirtek, Inc. ISO 17025 Accreditation Announcement
2011-11-22 00:00:00
After 10 years of diverse bioenvironmental research and testing, RespirTek has obtained ISO 17025 Certification and is continuing to improve upon the strong foundations of excellent customer service and quality testing that has served our clients wel... 

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