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Regulatory Review

    
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Myriad RBM, Inc.  Myriad RBM is a CLIA-certified biomarker testing laboratory specializing in cost-effective, high-quality multiplexing services. Our protein immunoassays benefit drug discovery & development from preclinical through Phase...
 
Services Provided Myriad RBM, Inc. is the world’s leading multiplexed immunoassay testing laboratory, providing comprehensive protein biomarker services based on its...
Allphase Clinical Research  Allphase Clinical Research is a clinical stage full-service Contract Research Organization (CRO) specializing in Respiratory, Oncology, Cardiovascular and CNS. Over the last 12 years we have run over 150 trials for small...
 
Medical Writing Our Scientific Affairs team provides strategic scientific guidance that effectively translates to comprehensive protocol designs and data analysis. Our...
 
Quality Assurance The Allphase Clinical Research Quality Assurance Team strives to provide thorough coverage for both our internal and external clients’ compliance oversight.
 
Pharmaphenix  Pharmaphenix is an international pharmaceutical consulting company specialized in the Business Development. Our main focus is in Emerging Markets where we run most of our projects. Key services that we offer: *...
 
International Platform Partner = sourcing company Customer = marketing company Oursourcing: * Promotion of products * Regulatory activities * Product development ...
PDG - Pharmaceutical Development Group, Inc.  Pharmaceutical Development Group Inc. (PDG) was founded in 1999 by Dr. Cheryl Blume and has quickly become a leading consulting firm serving both the pharmaceutical industry and the legal community. Headquartered in...
 
Regulatory Submissions PDG continues to lead the pharmaceutical industry as pharmaceutical regulatory and pharmaceutical product development strategists. The design and execution...
PDi-Pharmaceuticals  PDi was founded in the year 1978 and today counts among the top respected pharmaceutical distribution and Regulatory Service companies in Canada. PDi is a subsidiary of Heste Corporation, a diversified group with...
 
Regulatory Services PDi-Regulatory Services, a Division of PDi-Pharmaceuticals, Inc. provides contract consulting to the pharmaceutical industry. A team of outside associates...
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...
 
Regulatory Services Drugs and Veterinary Drug Pre-mix * Drug Establishment Licence Applications o Manufacturing, Packaging, Testing, Importing, Distribution and...
TCG  We are a group of senior executives who work with CEOs and other senior executives to help them develop sales, markets and business operations in the US medical device, pharmaceutical, diagnostics, and biotechnology...
 
Regulatory Affairs, Patent Actions & Reimbursement The US medical device market represents a huge profit opportunity for an innovative product -- but not if the launch is impeded by FDA problems,...
TopPharm Consulting  TopPharm Consulting company consists of people with high practical experience in EU regulatory affairs gained in Polish Authority and consulting companies. We are former Polish Authority experts who assessed dossier in...
 
Regulatory services preparation and translation of Summary of Product Characteristic (SmPC), Patient Information Leaflet (PIL), labelling including Braille
LDT Health Solutions  LDT Health Solutions, Inc. (LDT) is a Wayne, NJ based Healthcare Consulting Firm founded to provide the highest quality consulting services nationwide. LDT provides its expertise to all areas of pharmacy practice...
Clintrak Clinical Labeling Services, LLC  Clintrak, along with our corporate division, Fisher Clinical Services, are the leaders in global clinical supply chain solutions. Our vision is to leverage our expertise and global reach to offer a clinical labeling model...
Novumed  Novumed is an independent consulting firm for the life science industry. With offices in San Francisco and Munich Novumed is one of the largest specialized health care consulting firms with clear focus on pharma / biotech...
 
Regulatory Consulting The ever-changing global regulatory environments require deep understanding of key success drivers in order to define and implement regulatory strategies...
American Health Sciences Institute  The American Health Sciences Institute (AHSI) is a national leader in the delivery of skills-based training solutions to professionals in the drug discovery & development, health care, and regulatory environments. AHSI is...
Rondaxe  Rondaxe's expertise covers development & commercialization requirements: project management; process research & development; drug product development; regular, analytical and quality expertise; supply chain management;,...
 
Quality Assurance and Regulatory Strategy A senior level consulting group focused on providing cGMP Quality Assurance and Regulatory Strategy for development and manufacturing stage projects. Using...
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Regulatory Review Research Library

Allphase Clinical - Risky Business
Allphase Clinical Research
Executing a clinical development program without sufficient resources, experience, and planning is akin to starting a war armed with a pea-shooter. This is a trend that has been developing during these recession plagued years. Despite the counter-intuitiveness of the approach, one can sympathize given the incessant ticking of the patent clock and the difficulties in securing and maintaining ...
 
An Overview of Assay Quality Systems at Rules-Based Medicine
Myriad RBM, Inc.
Stringent guidelines of quality assurance and control (QA/QC) serve as the foundation for dependable and reproducible results in any analytical endeavor. Read step-by-step how the RBM platform combines the sensitivity and dynamic range of microsphere based immuno-multiplexing with the precision and dependability of automated liquid handling.
 
A Regulatory Review and Analysis of Independent Monitoring Systems for Temperature, Humidity and other critical parameters
Vaisala
While consolidation of technology helps to better understand our environment and improves response to mechanical and human failure, it is good practice to keep some functionality separate in the manufacturing of regulated medicines in Good Manufacturing Practice (GMP) facilities, specifically those systems that monitor critical environments and those that control the environments. Types of ...
 
Managing Clinical Trial Application (CTA) Acceptability to Support Phase I Clinical Studies in the United Kingdom
Celerion
Managing Clinical Trial Application (CTA) Acceptability to Support Phase I Clinical Studies in the United Kingdom Sarah Roberts, PhD, MTOPRA, RAC, Senior Director, Regulatory Affairs Fiona McNeilly, MBA, Site Director, Belfast Heimo Scheer, PhD, RAC, Vice President, Regulatory Affairs Abstract Aim: The EU Clinical Trials Directive (2001/20/EC) was implemented in the United Kingdom (UK) on 1st ...
 
The Regulatory Paradox - IVD
Beckloff Associates (Cardinal Health)
FDA's statutory jurisdiction, hence the regulatory obligations governing the design, characterization, production, and commercialization of laboratory developed tests (LDT), is defined in part by two central elements—(a) the degree of risk associated with the use of the device, and (b) the device's intended use. The development of increasingly more complex and sophisticated in vitro diagnostic ...
 

Regulatory Review Video

Confident care made possible - Cardinal Health Nuclear Pharmacy Services.mov Beckloff Associates (Cardinal Health) Customers and employees of Cardinal Health Nuclear Pharmacy Services discuss how Cardinal Health assists in providing confident care in the nuclear ...
 
Making possibilities possible - Cardinal Health Nuclear Pharmacy Services.mov Beckloff Associates (Cardinal Health) Customers and leaders of Cardinal Health Nuclear Pharmacy Services discuss the nuclear medicine industry and how Cardinal Health helps make ...
 
Regulatory Review Pharmaphenix Information

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