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  • mrregulatory.com
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Whether you're a seasoned regulatory affairs professional, FDA staffer, or someone looking to enter the field, we provide insights into how the agency works and how to communicate with FDA through the complex regulatory landscape to ultimately bring..

Relevance: 20.675774
  • hartmannwillner.com
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Navigating the FDA regulatory process can be challenging. We are a boutique FDA biologics consulting group specializing in biologics, biosimilars, biotechnology, and biologic device combination products. Our ex-FDA knowledge gives us a unique..

Relevance: 20.35129
  • fdapals.com
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FDApals is your partner for all your FDA Registration and FDA Approvals. We are your go to FDA consultant for all your regulatory needs right from FDA registration to warning letters replies and compliance. We at FDApals ensure 100% compliance with..

Relevance: 20.29672
  • www.pharmgenusa.com
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Pharmgen LLC., is a pharmaceutical clients based consultancy services group which works along with their clients in different areas like generic drug products development, all kind of regulatory submissions to US FDA, auditing firms and clinical..

Relevance: 20.251568
  • www.oconnellregulatory.com
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O'CONNELL REGULATORY CONSULTANTS, INC. is a consulting practice which specializes in medical device regulatory affairs and clinical study management, focusing on obtaining FDA marketing approval for medical devices and combination drug/device..

Relevance: 20.027931
  • www.pathmakerlaw.com
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Pathmaker FDA Law focuses only on businesses regulated by FDA or comparable international regulatory agencies...

Relevance: 19.888721
  • emmainternational.com
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EMMA International is a leading FDA compliance consulting firm. We provide cost-effective solutions for FDA regulatory affairs, compliance services, quality systems, remediation, regulatory filings and submissions. Our expertise includes medical..

Relevance: 19.802505
  • www.fdaregulatorycomplianceadvisors.com
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We provide technical and FDA regulatory knowledge to lay the foundation for optimized processes and robust systems that are key in the prevention of FDA-483s and FDA Warning Letters...

Relevance: 19.753498
  • www.ihlconsulting.com
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Combining over 100 years of FDA and Industry experience, IHL Consulting Group, Inc. is comprised of FDA consultants committed to providing a full range of consulting services in the areas of pharmaceutical, medical device, and biologics regulatory..

Relevance: 19.507008
  • reguliance.com
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REGULIANCE is a consulting firm focused on US FDA regulatory affairs for pharmaceutical and biopharmaceutical development and commercialization. Founded in 2002, Reguliance provides an array of services including FDA regulatory insight, strategy, and..

Relevance: 19.449625
  • www.lighthouseregulatory.com
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We efficiently guide clients navigating the complex medical device regulatory requirements and strive to expedite time-to-market. Our foundation is 15 years of industry and regulatory (FDA) experience which we will apply towards every stage of your..

Relevance: 19.121998
  • www.fdabasics.com
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FDAbasics has provided US agent and regulatory services for the last 20 years, supporting clients across the globe. We have expertise in handling regulatory matters and communication with the FDA, an essential element of successful consultancy..

Relevance: 19.101831
  • www.tpma.org.nz
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In its push for a global UDI system, the US FDA has close allies. Aligned with the goals of the US FDA is The Global Harmonisation Taskforce (GHTF)[3], a European based partnership established between regulatory authorities (including the US FDA) and..

Relevance: 19.094486
  • devicedesignsfda.com
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Device Designs FDA is a full service medical device consulting company specializing in engineering, antimicrobial treatment, device design, regulatory, engineering and technical writing... We can move yo ur devic es speedily through the FDA by doing..

Relevance: 19.036274
  • www.pharmatechconsulting.net
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Pharmatech Consulting Group, Inc. is an experienced, privately held company specializing in Food and Drug Administration (FDA) regulatory matters... PharmaTech Consulting consists of experts who know what FDA and other regulatory bodies require of..

Relevance: 18.884773
  • pharmobedient.com
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Pharmobedient Consultants are widely recognized within the pharmaceutical industry for the ability to help companies successfully resolve complex regulatory challenges. Whether it's preparing for an FDA audit, responding to an FDA audit, filing an..

Relevance: 18.839561
  • www.mdrsllc.com
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MDRS, LLC is an FDA registered company that specializes in providing strategic FDA and global regulatory, product development, quality and clinical research support to medical device and biotechnology companies and their development teams... MDRS,..

Relevance: 18.827486
  • www.fda-inspection.us
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FDA inspect establishments that manufacture, process or pack FDA regulated products like medical device, drug, cosmetic, food etc. FDA conduct random inspection with short notice to verify the GMP compliance. FDA ORA (office of Regulatory Affairs) is..

Relevance: 18.7722
  • www.dougmarconsultants.com
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Global Regulatory Affairs Consultancy that specializes in the areas of Regulatory Affairs for the cosmetic, OTC and personal care industries. Direct liaison with U.S. FDA and govering bodies...

Relevance: 18.733095
  • fdaconnection.com
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FDA Connection Group is an elite team of globally-certified regulatory, clinical, and quality system professionals whose track record of delivering sensible solutions assures customer needs are met. This proven commitment and credentials ensure that..

Relevance: 18.694979
  • acevalidation.com
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ACE is staffed with a group of professionals & subject matter experts with experience within the pharmaceutical industry. Over 18 years of validation & compliance experience, from small operations improvement projects, to building quality systems, to..

Relevance: 18.619368
  • loriacarrinc.com
President and CEO of Lori A. Carr, Inc., is a Principle Consultant in the Medical Device regulated industry... Lori A Carr, qualified FDA regulatory professional consulting with previous FDA medical device experience...

Relevance: 18.612698
  • www.matrixmedicaldevices.com
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From project management and regulatory submission, to post-market surveillance and remediation, Matrix Medical Devices is your regulatory and quality partner... Matrix Medical Devices provides the regulatory and quality expertise to navigate US FDA..

Relevance: 18.535667
  • only-orphans-cote.com
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Only Orphans Cote LLC is a regulatory affairs consulting firm leveraging its expertise and commitment to delivering drugs for rare diseases... Led by Dr. Tim Cote, the former Director of the FDA Office of Orphan Products Development (OOPD), and a..

Relevance: 18.522196
  • ifoodimports.com
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iFoodimports.com was established with an intention to assist growing needs and demands of domestic and foreign food, cosmetic and dietary supplements importers comply with FDA regulations and other US regulations. iFoodimports.com addresses the..

Relevance: 18.480015
  • aibmr.com
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Founded in 1978, AIBMR is one of the oldest natural product scientific & regulatory consulting firms in North America. We provide expert services which include GRAS Independent Conclusion (GRAS Self-Determination) studies, FDA GRAS notifications, NDI..

Relevance: 18.466837
  • www.precisionconsultants.com
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Precision Consultants is the world's premier advisor in matters related to FDA product approval, regulatory affairs and compliance. Through our global presence, we deliver strategy advice, compliance support and quality assurance leadership to..

Relevance: 18.435862
  • www.se-companies.com
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SE Consulting Group is a consulting company under SE Companies Group who is a leading provider of regulatory compliance, quality management systems, current good manufacturing practices (cGMPs), certifications and global sourcing services for FDA,..

Relevance: 18.40326
  • ismart.health
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iSmart's focus is on continuous research, development and product innovation. We work closely with the FDA and other regulatory authorities in evolving the regulatory framework, with a view to ensuring all of our marketed LED devices are both safe..

Relevance: 18.393858
  • www.regulatorycomp.com
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Regulatory Compliance Initiatives, a health care consulting firm assisting domestic and international companies with US FDA and international regulatory agency GMP, GCP and GLP requirements for drug substances, drug products, nutritional products,..

Relevance: 18.340908