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Biologics Register Biologics Consultants Submit Biologics Consulting Requests In the United States, biotechnology are subject to licensure under the Public Health Service Act. A biologic product is any virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, applicable to the prevention, treatment or cure of diseases or injuries to humans. Biological products include, but are not limited to, bacterial and viral vaccines, human blood and plasma and their derivatives, and certain products produced by biotechnology, such as interferons and erythropoietins. The FDA regulates biotechnology through it's Center for biotechnology Evaluation and Research (CBER). FDA's Center for biotechnology Evaluation and Research CBER is responsible for ensuring: the safety of this nation's entire blood supply and the products derived from it; the production and approval of safe and effective childhood vaccines, including any future AIDS vaccines; the proper oversight of human tissue for transplantation; an adequate and safe supply of allergenic materials and anti-toxins; the safety and efficacy of biological therapeutics, including an exciting new array of biotechnology-derived products used to treat diseases such as cancer and AIDS. . : . The PHS Act requires individuals or companies who manufacture biotechnology for introduction into interstate commerce to hold a license for the products. These licenses are issued by FDA's Center for biotechnology Evaluation and Research (CBER). Biological products intended for veterinary use are regulated under a separate law, the Virus, Serum, and Toxin Act, which is administered by the U.S. Department of Agriculture. Manufacturers of those products are now required to submit only a biotechnology license application (BLA), Register Regulatory Consultants Submit Regulatory Requests for Proposals For more information, please contact Global Regulatory Inc. at 403-770-1994 or email Global Regulatory Global Regulatory .com can assist your company in finding Regulatory Consultants for legal and regulatory services such as submissions, certifications, licensing, quality systems, technical writing, importing / exporting, expert witnesses, audits, consulting, scientific reviews, designated agents, compliance, validation, qualification, training, etc in industries such as: Pharmaceuticals Biotechnology Medical Devices Healthcare Medicine Food and Beverage Nutraceuticals Clinical Trials Telecommunications Biologics Environmental Veterinary Medicine Plastics In-Vitro Diagnostics Electronics   Please visit our other websites: Contract Laboratory .com   FDA Inspections .com

International Regulatory News 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 ...  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...  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...  UKAS Accreditation for Inspection of Fairground and Amusement Park Devices - Pilot Project Update 2011-11-11 00:00:00 The first pilot assessment by UKAS of an inspection body involved in inspection of fairground and amusement park devices is now under way. A pre- assessment of Jacobs Engineering (UK) Ltd, Ashton Lane, Manchester was conducted by UKAS recently, wher...  ACCREDITATION MATTERS ISSUE 8 NOW AVAILABLE 2011-11-08 00:00:00 A new edition of Accreditation Matters, UKAS' newsletter for the public sector, has been released. Issue 8 gives information about the appointment of UKAS as the accreditation body for the Green Deal, the Government's flagship programme for improving...  Nova now provides Sterility and Endotoxin Testing for the Radiopharmaceutical Industry 2011-11-01 00:00:00 Radiopharmaceutical sterility testing is required during the sterilization validation process as well as for routine product release testing. USP <71> sterility testing is an official test to determine sterility of a product. Nova's understanding of ...  FDA invests $2 million in partnerships through Centers of Excellence in Regulatory Science and Innovation 2011-10-26 00:00:00 The U.S. Food and Drug Administration today announced the award of $2 million to support two regional Centers of Excellence in Regulatory Science and Innovation (CERSI). The centers, which will be located at the University of Maryland and Georgeto...  2011-10-26 00:00:00 FDA approves first generic olanzapine to treat schizophrenia, bipolar disorder The U.S. Food and Drug Administration today approved the first generic versions of Zyprexa (olanzapine tablets) and Zyprexa Zydus (olanzapine orally disintegrating tabl...  FDA approves Onfi to treat severe type of seizures 2011-10-26 00:00:00 On Oct. 21, the U.S. Food and Drug Administration approved Onfi tablets (clobazam) for use as an adjunctive (add-on) treatment for seizures associated with Lennox-Gastaut syndrome in adults and children 2 years of age and older. As Onfi is intended t...  Illinois warehouse Prevents unsafe food distribution from rodent-infested facility 2011-10-19 00:00:00 FDA: U.S. Marshals seize food products at U.S. Marshals, acting at the request of the FDA, seized various food products stored in a warehouse owned by Chetak Chicago LLC, in Streamwood, Ill., on October 17, 2011. The products were seized under a warr...

International Regulatory News 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 ...  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...  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...  UKAS Accreditation for Inspection of Fairground and Amusement Park Devices - Pilot Project Update 2011-11-11 00:00:00 The first pilot assessment by UKAS of an inspection body involved in inspection of fairground and amusement park devices is now under way. A pre- assessment of Jacobs Engineering (UK) Ltd, Ashton Lane, Manchester was conducted by UKAS recently, wher...  ACCREDITATION MATTERS ISSUE 8 NOW AVAILABLE 2011-11-08 00:00:00 A new edition of Accreditation Matters, UKAS' newsletter for the public sector, has been released. Issue 8 gives information about the appointment of UKAS as the accreditation body for the Green Deal, the Government's flagship programme for improving...  Nova now provides Sterility and Endotoxin Testing for the Radiopharmaceutical Industry 2011-11-01 00:00:00 Radiopharmaceutical sterility testing is required during the sterilization validation process as well as for routine product release testing. USP <71> sterility testing is an official test to determine sterility of a product. Nova's understanding of ...  FDA invests $2 million in partnerships through Centers of Excellence in Regulatory Science and Innovation 2011-10-26 00:00:00 The U.S. Food and Drug Administration today announced the award of $2 million to support two regional Centers of Excellence in Regulatory Science and Innovation (CERSI). The centers, which will be located at the University of Maryland and Georgeto...  2011-10-26 00:00:00 FDA approves first generic olanzapine to treat schizophrenia, bipolar disorder The U.S. Food and Drug Administration today approved the first generic versions of Zyprexa (olanzapine tablets) and Zyprexa Zydus (olanzapine orally disintegrating tabl...  FDA approves Onfi to treat severe type of seizures 2011-10-26 00:00:00 On Oct. 21, the U.S. Food and Drug Administration approved Onfi tablets (clobazam) for use as an adjunctive (add-on) treatment for seizures associated with Lennox-Gastaut syndrome in adults and children 2 years of age and older. As Onfi is intended t...  Illinois warehouse Prevents unsafe food distribution from rodent-infested facility 2011-10-19 00:00:00 FDA: U.S. Marshals seize food products at U.S. Marshals, acting at the request of the FDA, seized various food products stored in a warehouse owned by Chetak Chicago LLC, in Streamwood, Ill., on October 17, 2011. The products were seized under a warr...

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