Top Regulatory And Compliance Solution Companies - 2020
The Innovation Process: Developing Lifesaving Medtech

Top 10 Regulatory And Compliance Solution Companies - 2020

At the beginning of this decade, the healthcare compliance and regulatory leaders around the world were focussed mainly on drugs. However, today, with the industry entering 2020, the umbrella has widened, and several factors like data-driven approach, technology regulation, and maintaining transparency have become the epicenter. This year, the regulators are focussed increasingly on making fair use of big data, wearables, and biosimilars to exercise better control on the available patient data. With this in mind, the regulators are hiring seasoned data scientists and technologists who will develop the future demands and automation of the compliance process along with driving innovation into the industry.

To help companies looking for a suitable regulatory and compliance partner, MedTech Outlook has compiled a list of the leading regulatory and compliance solution providers that are at the top of their game. Through their incomparable cutting-edge technologies, these companies are set to transform the healthcare regulatory landscape. We hope this issue of the MedTech Outlook helps you build the partnership you and your firm needs to foster a technologically-driven, yet sustainable business.

We present to you MedTech Outlook’s “Top 10 Regulatory and Compliance Solution Providers – 2020.”

    Top Regulatory And Compliance Solution Companies

    Arazy Group Consultants
    Headquartered in Vancouver, BC, and founded in 1995, Arazy Group Consultants Inc., a global regulatory affairs firm, provides technology services and products formulated to simplify, streamline, and expedite international market access affairs for various types of medical and IVD devices. The company allows its clients to register multiple medical devices in over 100+ markets simultaneously, reducing their overall price by as much as 50% and enter new markets 1-4 months sooner. Arazy Group Consultants Inc. specializes in Global Medical Device Registration, Medical Device Safety Compliance, Quality Management System, Universal Representation & Administration, Clinical & Medical Research, Cloud technologies, Regulatory Affairs
    Celegence
    The company assists life sciences companies navigate complex global regulatory requirements by providing expert consulting services and solutions dedicated to regulatory affairs. It offers high-quality medical device regulatory consulting for each step of the product lifecycle. The company assists its customers in the areas of regulatory intelligence, medical writing, RIMS, publishing, labeling, and compliance with new regulations for different product portfolios. Celegence works across all phases of the product lifecycle, from regulatory strategy, authoring, to all aspects of product maintenance, including submission management, publishing, and health authority interaction
    Quality Systems Compliance LLC
    Quality Systems Compliance LLC was founded in 2012 as an opportunity to tend to the needs of businesses functioning in the FDA Regulated Industries inclusive of Medical Devices, Pharmaceuticals, Tissue. They help to achieve and maintain quality compliance while meeting deadlines and containing costs. If the quality systems are implemented correctly in the initial stage can reduce liability and risk. With the assistance of Quality Systems Compliance, LLC, the clients can achieve a QUALITY SYSTEM plan that will make the client compliant as well as profitable. The company's specialties lie in Quality Compliance, Quality Assurance, Quality Systems, and Quality Control
    SpectRA Compliance
    SpectRA Compliance, LLC believes in protecting public health and providing access to best in class medical products and health care services globally. In order to champion the continued introduction of safe and effective medical devices to the public, SpectRA partners with industry, regulators, and the public to provide specialized Regulatory Affairs and Quality solutions. SpectRA Compliance caters their services mainly to small and midsize medical device and pharmaceutical companies. At SpectRA, they do not believe in one size fits all consulting. Instead, they strive to develop resources, services, and strategies that are specifically designed for individual clients to fit their needs
    Emergo by UL
    Founded in 1997 and headquartered in Austin, TX, Emergo by UL provides quality and regulatory compliance consulting to medical device and IVD companies. They assist with medical device registration/approval, organizational strategy, ISO 13485 and QMS compliance, local in-country representation, and post-market surveillance in 20+ markets worldwide. Emergo by UL provides real-time service and on-the-ground expertise. The company expertise in Regulatory strategy and consulting, QMS implementation and audits, Medical device and IVD registration, Clinical data evaluation and PMCF, In-country regulatory representation, Post-market surveillance consulting
    Enhanced Compliance
    Founded in 2012, Enhanced Compliance Inc. offers compliance consulting services to the life sciences industries. They specialize in the medical device, pharmaceutical, biotech, and nutritionals market sectors. The company provides a range of flexible and comprehensive services to ensure our clients meet FDA and global compliance regulation requirements, along with ensuring quality, efficacy, and safety in bringing to market innovative life-changing – even life-saving – advancements in the life sciences field. Their services include Non-Compliance (Consent Decree and Warning Letter) Remediation, Regulatory Compliance, Program Management, Manufacturing, Research & Development, Validation, and Technical Services
    Jama Software
    Founded in 2007, Jama Software provides innovative analytics, solutions, and insights to the companies producing mission-critical software systems and complex products. With an expanded product and service capabilities, the Jama Product Development Platform allows large enterprises to fasten development time, slash complexity, mitigate risk, and verify regulatory compliance. Showcasing the forefront of modern development, its rapidly growing customer base of more than 600 organizations Jama Software streamlines processes and brings complex products to market. With the help of Predictive Product Development, Jama enables its customers to derive the most of their revenue potential and gather ongoing competitive advantages
    mdi Consultants
    Based in Great Neck, New York, and founded in 1978, mdi Consultants, Inc. provides consulting services to the healthcare industry worldwide. They have extensive expertise in helping medical device, pharmaceutical, biotechnology, and food companies achieve compliance with U.S., European, and Canadian regulations. mdi Consultants, Inc. specializes in FDA 510(k) Assistance, FDA Regulatory Review, 483 Response, Warning Letter Response, ISO 13485, Implementation, QSR/cGMP Compliance, FDA Training, Regulatory Strategy, 513(g), 510(k) Pre Submissions, Device/Product Label Review
    MethodSense
    Based in Morrisville, NC, MethodSense is a global life science consulting firm, providing services and solutions in regulatory strategy, quality assurance, technology, and operations. Supported by InfoStrength, MethodSense’s custom-designed regulatory-compliant information management software, they help clients maintain compliance throughout the lifecycle of their business, from product design and development through FDA clearance or CE marking and post-market activities. With a combination of their experience and skills across the medical device sector, MethodSense works at the intersection of engineering and quality to help clients meet compliance requirements, improve their performance and create sustainable value for their stakeholders
    Propel
    Headquartered in Santa Clara, California, and founded in 2015, Propel is the platform for tomorrow’s brands. Propel provides cloud Product Lifecycle Management (PLM), Quality Management Software (QMS, and Product Information Management (PIM) solutions that allows the engineers, sales channels, marketing, partners, customers, and everyone else to share all the information needed to get the products from concept to customer. Built on the Salesforce platform, Propel’s SaaS-based software helps everyone collaborate better, takes just weeks to get up and running, and can quickly scale with changing business requirements