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I N T E R N A T I O N A L R E G U L A T O R Y C O N S U L T A N T S, L. C. Company Profile

10:56 EST 10th December 2018 | BioPortfolio

International Regulatory Consultants is an organization of highly qualified professional regulatory and quality system consultants with an average of 25+ years industry / FDA related experience. Founded in 1989, we specialize in helping manufacturers of medical products coordinate North American, European, Asian and Pacific Rim regulatory affairs and quality systems compliance activities. Our clients have and continue to include both large and small companies in the US, Canada, Europe, the Middle East, and Asia.

WHAT WE DO:

IRC offers a complete range of services which include highly important strategic regulatory business planning. IRC maintains strategic operations to help service our European and Asian clients with a variety of services for regulatory and quality system requirements including biocompatibility and microbiological testing. The array of services encompass regulatory product submissions/dossiers for product approvals; planning, administration, analysis, and management of clinical and non-clinical research; quality systems (GMP/ISO) audit, analysis and design; design assurance and control; preproduction technology transfer and validation; compliance crisis management, including FDA inspection issues, FDA Warning Letters, detention, injunctions, and consent decree requirements; and, training programs for both regulatory and quality systems.

Our collaboration with certain highly qualified and cost effective European based consulting firms to provide service as a required Authorized Representative affords our clients the opportunity to utilize IRC services along with that of the Authorized Representative to help ensure compliance with CE Mark requirements. In addition, our affiliation with MedLink Europe, affords our clients both the opportunity and capability of having a highly effective marketing and distribution network, including assistance towards establishing strategic alliances for manufacturing and operations within the EEU.

Our affiliation with Vector Resources L.C. in the U.S. enables IRC to help clients find critical path solutions to their marketing, sales and partnering needs. OUR STAFF key staff personnel have significant experience in representing clients as US Agent and Official Correspondent before the US Food and Drug Administration. In addition, IRC maintains strategic affiliations on global basis which when necessary enables our organization to fully serve those clients in a shrinking regulatory compliance world. With proven expertise in US FDA medical device and biotechnology product regulations, current Quality Systems and GMP regulations, the latest European Medical Device / In Vitro Diagnostic Device Directives, and ISO series quality standards. IRC is the unquestionable choice as a consultancy. This know-how has been placed into practice in our continued demonstration to be in the solution rather than the problem.

Location

7651 S. 700 West, Suite 105
Salt Lake City
Utah
84047-7101
United States of America

Contact

Phone: 801 233-0075
Fax: 801 233-0089
Email: info@irclc.com


News Articles [443009 Results]

Aeglea BioTherapeutics Announces Positive Clinical Updates

While some companies wait until clinical trials are finished with dosing and collecting data to begin releasing information, those that release interim data can give investors a better handle on how t...

Pigment Epithelium Derived Factor: Characterization, Genomic Organization and Sequence of PEDF Gene

Retinal pigment epithelium (RPE) cells secrete a unique 50 kD protein. This protein, pigment epithelium-derived factor (PEDF), contains trophic activity in both the induction of neuronal cell differen...

Pigment Epithelium Derived Factor: Characterization of Its Novel Biological Activity and Sequences Encoding and Expressing the Protein

Pigment epithelium-derived factor (PEDF), a unique 50 kD protein secreted by retinal pigment epithelium (RPE) cells, has trophic activity. This invention describes the biological activity of PEDF, a m...

AAV4 Vector And Uses Thereof

These patent applications describe the cloning and characterization of the full-length genome of adeno-associated virus type 4 (AAV4). AAV4, like other members of the AAV family, may be useful as a ve...

Virally Mediated Gene Therapy For The Control Of Chronic Or Persistent Pain

Current treatments for pain, especially chronic pain, are only partially effective and can eventually involve procedures that are invasive or associated with unacceptable side effects. In vivo gene tr...

Method of Diagnosing Multidrug Resistant Tuberculosis

The invention can be used to develop tests that are much more rapid than conventional tests for determining drug resistance. It relates to the discovery that a putative gene of Mycobacterium tuberculo...

Ocular Therapeutic Agent Delivery Devices And Methods

The invention is directed to ocular implant devices for the delivery of therapeutic agents to the eye in a controlled and sustained manner. Implants suitable for either subconjunctival or intravitrea...

Parallel Measurements of Multiple Macromolecules Using a Cryoarray

Available for license is a new improved technique for the creation of biological arrays of 25-100 biological samples per slide, for use in parallel molecular screening in medical research and clinical...

PubMed Articles [1002839 Results]

Effects of proinsulin misfolding on β-cell dynamics, differentiation and function in diabetes.

ER stress due to proinsulin misfolding has an important role in the pathophysiology of rare forms of permanent neonatal diabetes (PNDM) and probably also of common type 1 (T1D) and type 2 diabetes (T2...

Regulation of islet glucagon secretion: Beyond calcium.

The islet of Langerhans plays a key role in glucose homeostasis through regulated secretion of the hormones insulin and glucagon. Islet research has focused on the insulin-secreting β-cells, even tho...

Biosynthesis, structure, and folding of the insulin precursor protein.

Insulin synthesis in pancreatic β-cells is initiated as preproinsulin. Prevailing glucose concentrations, which oscillate pre- and postprandially, exert major dynamic variation in preproinsulin biosy...

Role of ghrelin in pancreatic development and function.

Ghrelin is a gastric peptide with anabolic functions. It acutely stimulates growth hormone (GH) secretion from the anterior pituitary glands and modulates hypothalamic circuits that control food intak...

Lysosomes in nutrient signalling: A focus on pancreatic β-cells.

Regulated insulin secretion from pancreatic β-cells is a major process maintaining glucose homeostasis in mammals. Enhancing insulin release in response to chronic nutrient overload and obesity-relat...

Clinical Trials [163034 Results]

The Utility of Peri-operative Arnica Montana for Reduction of Ecchymosis in Rhinoplasty Surgery

Arnica montana is a homeopathic drug that is made in accordance with the official methods of the Homeopathic Pharmacopoeia of the United States (HPUS) and is commonly used by cosmetic surg...

Pharyngeal Size in Patients With Obstructive Tonsils Under Orthodontic Treatment

Enlarged tonsils and malocclusion has relationship with sleep disturbance in children. The consequences of these features can include aggravation of craniofacial growth such that the devel...

The Biology of Chronic Preconditioning: Genomic and Physiologic Mechanisms of Response

The purpose of this study is to assess the effects of repeated RIPC and exercise, on exercise performance, skeletal muscle responses and circulating cellular and humoral biology in humans

Pilot Study of Raltegravir Lipodystrophy IISP

The substitution of raltegravir for the NRTIs will result in some reversal of the long term adverse effect of lipodystrophy (specifically peripheral lipoatrophy) that is associated with th...

Esophagoscopy in Evaluating Treatment in Patients With Stage I-IV Head and Neck Cancer Who Are Undergoing Radiation Therapy and/or Chemotherapy

Brief Summary: RATIONALE: Comparing results of diagnostic procedures, such as esophagoscopy, done before and after radiation therapy and/or chemotherapy may help doctors predict a patient...

Companies [55431 Results]

Biogen Idec Inc.

Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufa...

Compugen Ltd.

Compugen is a leading drug and diagnostic product candidate discovery company. Unlike traditional high throughput trial and error experimental based discovery, Compugen's discovery efforts are b...

Schiff Nutrition International, Inc.

Schiff Nutrition International, Inc. develops, manufactures, markets and distributes branded and private label vitamins, nutritional supplements and nutrition bars in the United S...

Fero Industries, Inc.

Fero Industries, Inc. is a publicly traded holding company (OTC BB: FROI.OB). Fero’s mission is to acquire healthcare related companies, products, and technologies that have large market poten...

Water Pik, Inc.

Water Pik is a leading developer, manufacturer and marketer of innovative personal healthcare products sold under the Waterpik® brand name. The Company has developed and introd...

More Information about "I N T E R N A T I O N A L R E G U L A T O R Y C O N S U L T A N T S, L. C." on BioPortfolio

We have published hundreds of I N T E R N A T I O N A L R E G U L A T O R Y C O N S U L T A N T S, L. C. news stories on BioPortfolio along with dozens of I N T E R N A T I O N A L R E G U L A T O R Y C O N S U L T A N T S, L. C. Clinical Trials and PubMed Articles about I N T E R N A T I O N A L R E G U L A T O R Y C O N S U L T A N T S, L. C. for you to read. In addition to the medical data, news and clinical trials, BioPortfolio also has a large collection of I N T E R N A T I O N A L R E G U L A T O R Y C O N S U L T A N T S, L. C. Companies in our database. You can also find out about relevant I N T E R N A T I O N A L R E G U L A T O R Y C O N S U L T A N T S, L. C. Drugs and Medications on this site too.

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Diagnostics
A diagnostic test is any kind of medical test performed to aid in the diagnosis or detection of disease. For example: to diagnose diseases to measure the progress or recovery from disease to confirm that a person is free from disease Clin...


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