regulatory consulting companies

Without this, you could find your consulting engagement straddling multiple regulatory deadlines and delaying your commercialization process. Kroll's Financial Services Compliance and Regulation practice combines a financial services focus, real world experience, independence and a united global team to help clients: Minimize risks related to compliance and regulation, from routine tasks to complex challenges. Develop and sustain a competitive advantage. Regulatory Affairs consulting services - Key considerations. The principal, Michael Nilo, has 10 years of experience in the medical device industry, including 5+ years as a lead reviewer at the Food & Drug Administration. Clinical Trials: Regulatory Consulting for Clinical Trials, Recruitment strategies, Advertisement campaigns, Social Media Campaigns, Patient Support (Toll-free, online and email screening). Regulatory Affairs Consulting Firms will sometimes glitch and take you a long time to try different solutions. CyberSecOp provides high-end cyber security consulting services and incident response support for organizations worldwide. Clients will gain access to valuable guidance from regulatory experts. Regulatory consulting services are especially geared to early drug development programs. For inquiries on FDA regulatory services and quality assurance solutions, please contact Prashant Kumar at 410-501-5777 or write to pkumar@fdamap.com. Freyr's global Regulatory affairs services enable Life Sciences, Consumer Pharma and Bio-Med companies to understand and efficiently manage the demanding complexity of the diverse Regulatory requirements in . Klein Hersh can address your pressing functional needs and seamlessly augment your team, by providing access to experienced regulatory professionals on a contract basis. Competing priorities and differing stakeholder definitions of value require creative, connected strategies that maximize each stage of development. Helping you to implement regulatory change in an informed, efficient and effective way. Metz Regulatory Consulting Services, LLC is a North Carolina Domestic Limited-Liability Company filed On January 24, 2011. Regulatory Consulting Services. Managing risk for patient health and safety. Furthermore, you can find the "Troubleshooting Login Issues" section which can answer your unresolved . Regulatory Matters. Our team of over 500 industry experts offers the hindsight and advantage necessary to . When your staff resourcing levels need extra support, Klein Hersh delivers the flexible capacity you require to manage due . Our highly qualified and experienced . Minimize business impacts such as loss of sales, product recall, and obsolete inventory. The team enjoyed the opportunity to be back in person to share. Our experts are adept in handling end-to-end market authorizations and product life-cycle management of all major HAs like, the United States Food and Drug Administration (US FDA), the . We Take Your Quality & Regulatory Compliance Seriously. ProPharma group is the world's leading regulatory consulting company. Contact RCA for Medical Device Regulatory Consulting Services. This report segments the global Cosmetics Regulatory Compliance Consulting Services market . For over 25 years, Q&C has helped businesses determine their appropriate licencing solutions and apply for and obtain the requisite licences and permits. He has direct . Their services cover all areas of FDA regulations that are responsible for governing the production and distribution of medical devices. They apply extensive health and environmental legislative knowledge . A Leader in Global Regulatory Consulting Services Dunn Regulatory Associates, LLC's expertise is in the development of Rx and OTC pharmaceuticals, biopharmaceuticals, and devices. LBR professionals develop efficient individualized strategies to navigate the development process. Ogier Regulatory Consulting is expert in regulatory requirements, drawing on experience as regulators, advisors, policy makers and practitioner compliance officers. At AARIYA, we offer our clients highly professional and effective services to all of their Regulatory Affairs requirements. Although science is evolving for any drug program, keeping an eye on the desired drug label is a winning strategy to making sound . Our experts are highly knowledgeable in the core sciences and public policy decisions that are used to structure and implement regulations governing the manufacture, use, and marketing of chemicals and chemical products. The leader in global health and environmental services provides complete green regulatory access and strategy services to support all levels and sizes of trade. Achieve end-to-end regulatory compliance. Tel: +44 (0)203 954 3606 Email: [email protected] Novotech uses state-of-the-art pharmacovigilance platform, Oracle ARGUS, for safety monitoring and case processing. Parexel Regulatory Consulting Services. Find an Expert Regulatory Affairs Consultant. SARACA is a global IT consulting and engineering R&D services company with Fortune 500 customers. The Accounting, Finance & Technology category consists of Accenture, Booz Allen, Deloitte, KPMG, EY, PwC, and Wavestone. We help clients navigate the ever-changing global regulatory and quality landscape and deliver customized solutions . +1 415 783 5413. Our knowledgeable team will guide you through the regulations so you can gain market access quickly, successfully, and with confidence. If any delays occur, costs in both time and money can rapidly escalate. I3CGLOBAL is a vibrant and customer-focused company that provides healthcare product manufacturers across the globe with US, EU & India medical device regulatory consultants services. Insight Regulatory Consultancy Ltd provides medical device consulting and medical device regulatory consulting services to the medical device industry. BIORIUS offers consulting services to ensure the compliance of your products and ingredients, manage risks and propose successful strategies. Freyr with an updated knowledge over the region helps manufacturers navigate the Regulatory complexities for a successful compliance. Regulatory Services Provided: Ken Block Consulting offers a variety of services to address the needs of medical device inventors and companies, both those that are new to FDA regulations and those that have established regulatory affairs departments in need of additional assistance. Alex Brady. Since 1999, we've been laser-focused on providing . Listed in the expandable menus on this page are examples of . Dissolved and its File Number is 1185389. Know more about I3CGLOBAL. Whether your goal is EU MDR, IVDR or FDA compliance, we've got the consultant for you. Clients need proactive regulatory, compliance and AML consultancy services to help identify, manage and respond to issues even before they arise. Regulatory consulting. As FDA Pharmaceutical regulatory consultants since 1999, PDG is continuously engaged with FDA in meetings and negotiations on behalf of our clients. I3CGLOBAL insists on honesty, integrity, and fairness in all aspects of our business and expects the same in its relationships with . New laws, regulations and shifting public expectations have pushed governance and compliance up the boardroom agenda. Ensure global health and environmental compliance for your products. Support includes consulting for production and manufacturing facility design, regulatory strategic planning and due diligence for US and International based customers or projects that need extensive and relevant . EVERSANA has a proven track record of providing best-in-class regulatory and quality support at any phase of the product life cycle to companies in the rare disease, medical device, pharmaceutical, biologic and HCT/P industries. 1. Companies that lack an in-depth understanding of the regulatory framework could be missing out on important market opportunities. PwC's bank regulatory compliance team is well qualified to assist banking companies in addressing these challenges and staying abreast of changing regulatory requirements, expectations and industry practices. Regulatory Consulting and Services. Knowing and interpreting regulations and guidelines, and having the right strategy, the right data, and the right presentation is important for expeditious review and FDA approval of your medical device. ANNUAL PROCEDURES AND CONTROLS ASSESSMENT. Our . Additionally, we can conduct the testing of your controls as required by FINRA Rule 3120. Compelling evidence and a convincing value proposition matter. We can help you formulate the right strategy to bring your medical device to market - and keep it there. Clinical trial transparency including complete trial disclosure lifecycle management. Regulatory Affairs Consultants (90 companies found) Compare and research Regulatory Affairs Consultants companies and businesses online. EAS Consulting Group is a consulting firm that provides regulatory solutions for industries including foods, pharmaceuticals, dietary supplements, and more. 4. Working with your technical documents, we will ensure your registration applications are submitted in line with Health Canada regulations. Our regulatory consultants have expertise in oncology, orphan drugs . Conducting literature searches and data . Designing and placing of studies to support the safety and efficacy (utility) of a feed ingredient for the intended use in the intended species or target animals. Design and implement a compliance management policy and organization for effective oversight and reporting of critical non-compliances. Drug developers need a regulatory roadmap to navigate through development programs where there is substantial uncertainty. Our services include: Developing successful regulatory strategies and conducting feasibility assessments to determine scientific data gaps. Drive efficiency by developing, implementing and managing tailored, risk . AsiaCRO is offering wide range of Regulatory . Our cyber security customer service support can be contacted using the Contact Us form, or you can reach our live customer service representatives 24/7 using our Live Chat and 866-973-2677. They have over 150 independent advisors and consultants providing consulting, training, and auditing services to ensure regulatory compliance. Novotech's Medical Services is aligned to client's protocol-specific requirements and geared towards the delivery of targeted clinical parameters; while also providing both medical and safety oversight and regulatory support. With our regulatory affairs consulting services we will support you through planning, submission, and post-submission approval. Government & Regulatory Bodies Biotechnology, Pharmaceutical, Research & Academic Organisations Biotech, Biomedical & Biomanufacturing Equipment Founded in 1987, AccuReg works with clients world-wide to bring new products to market and maintain compliant Quality Systems. Biologics Consulting attends RAPS Convergence. Regulatory services. With Intertek's regulatory consulting and strategy services, companies can effectively: Manage compliance strategy and risks. 2. . Different by Design. Establishment Licence Applications and Amendments for Drugs (DEL), Natural Health Products (NHP Site License) and Medical Devices (MDEL . Our full range of strategic and operational regulatory services include support for: Advanced therapy medical products (ATMPs) Biosimilars. We assist with products in all three medical device classes, including software products, active implantable devices, combination products as well as pharmaceutical products. 80% of our customers are based in United States of America (USA) with 95% recurring business. Our clients range from development stage biotech companies to mid-size and large pharmaceutical companies. They also spend a lot of time focused on operations, financial engineering, and turnaround consulting. We specialise in Regulatory and Technical advice for markets including Australia, New Zealand, Europe, United Kingdom, United States, Canada, Russia, Middle East, South Africa and ASEAN Countries. Our team is deeply experienced in providing consulting solutions for companies in all aspects of Quality & Regulatory Compliance. Ken Block Consulting focuses on helping companies produce safe and effective medical devices for both U.S. and international markets. Nilo Medical Consulting Group is a limited liability company that provides medical industry consulting services based out of the Pittsburgh, PA and Portland, OR areas. Executive Regulatory Consulting Specialists. We Help Drug Companies Navigate The FDA. Preferred Regulatory Consulting provides regulatory, quality, and clinical services to medical device and pharmaceutical companies at all stages of their development. Biologics and biotech products. CATO SMS has more than 30 years of experience in consulting in multiple product development areas including: Preclinical safety, toxicology, pharmaceutical development, CMC, Cell & Gene Therapy, PK/PD development, clinical strategy, medical writing, regulatory affairs and regulatory submissions. The Registered Agent on file for this company is Metz, Craig A. and is located at 9008 Laura Lake Drive, Wake Forest, NC 27587. . Navigating the Global Regulatory Landscape. We provide services in medical technology, aerospace,defence, rail . Ensuring regulatory compliance is essential to the success and growth of a brand. Ardena. Expertise in Expedited Drug Development Approvals. Using an experience-based approach that integrates scientific expertise, business acumen, and regulatory strategy, we can streamline your product's development . However, entering the region challenges the manufacturers with complex Regulatory regime of Qatar. 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