Regulatory Affairs | Ohio Life Sciences

CMD MedTech, LLC

Scott Gray — Sun, 02 Jul 2023 16:14:02 +0000

CMD MedTech, LLC is a professional services firm focused on improving the quality of life for patients and caregivers worldwide by partnering with our customers to develop safe, effective, and compliant healthcare products. Services include systems engineering, project management, quality & regulatory, and design & development engineering.

JALEX Medical, LLC

Scott Gray — Sun, 02 Jul 2023 16:25:14 +0000

JALEX Medical, LLC offers medical device design, product development, and regulatory consulting. Device design capabilities include concept generation, design for manufacturability, material selection, and prototype development. The company’s range of regulatory services include ISO 13485 training, internal/supplier auditing assistance, FDA risk assessment, and assistance with 510(k) submissions, regulatory documents, product classifications and continuous education to clients on regulatory changes.

Matrix Medical Devices, LLC

Scott Gray — Sun, 02 Jul 2023 16:28:11 +0000

Matrix Medical Devices offers a robust regulatory and quality foundation, enabling an efficient development process for current and future products. In addition, we offer other resources for growth including due diligence, organizational assessment, design transfer guidance and a quality supplier network.

RJR Consulting, Inc.

Scott Gray — Sun, 02 Jul 2023 16:40:48 +0000

RJR Consulting, Inc. is a global regulatory compliance consulting company supporting clients in the pharmaceutical, biologic, medical device, combination product, supplement, cosmetic, and food industries. RJR and its affiliates have offices in over 40 countries and cover more than 90 countries for its clients. 80% of client requests are for ex-US support with the remaining being assistance with U.S. FDA. Services include: product registration/variations/renewals, license holder/agent services, GMP/ISO compliance & certification support, in-country representation, DMFs/local agent, labeling compliance, quality services & validations, pharmacovigilance, device reporting, clinical trial applications & support, global expansion support, and global regulatory intelligence.

Tunnell Consulting, Inc.

Scott Gray — Sun, 02 Jul 2023 16:46:32 +0000

Tunnell Consulting has solved complex problems for life sciences companies since our inception over 50 years ago, and we have had a sole focus on the industry since 2000. Few other consulting firms can make such a claim. We bring to every assignment a powerful combination of life sciences subject matter expertise and depth of experience that other firms find difficult to match. Our expertise ranges from strategy-level decisions made in the Board Room and C-Suite, to operational decisions made on the shop floor. And it covers the full spectrum of technical, operational, quality, compliance and regulatory challenges. We don’t require a long learning curve, which translates into faster payback and a greater return on your investment.

Advarra

Scott Gray — Sun, 02 Jul 2023 16:04:51 +0000

Advarra (formerly Schulman IRB and Chesapeake IRB) is the premier provider of institutional review board (IRB), institutional biosafety committee (IBC) and research quality and compliance consulting services in North America. Fully accredited by AAHRPP, Advarra serves the world’s leading pharmaceutical, biotechnology, medical device and contract research organizations, as well as academic medical centers, hospital systems, investigative site networks and therapeutic research consortia. To address the increasingly complex needs associated with research, Advarra leverages exceptional client service, innovative technology and robust global regulatory expertise. Advarra also provides deep experience across all major therapeutic areas and continues to pioneer highly specialized review services for areas such as oncology and neurology. Above all, Advarra provides integrated compliance services with unprecedented clarity, helping you navigate regulatory requirements more confidently.

ClearMark (a Kaleidoscope Company)

Scott Gray — Sun, 02 Jul 2023 16:13:25 +0000

ClearMark provides a cloud-based electronic QMS specifically developed for medical device entrepreneurs, designers, and manufacturers. With a QMS that supports your business and organizes your team, products are developed on schedule and within budget. At ClearMark we believe your QMS should do more than just ensure compliance to ISO 13485 and 21 CRF 820; it should support your project goals from concept to post-market.

Clinical Research Consultants, Inc.

Scott Gray — Sun, 02 Jul 2023 16:13:45 +0000

Clinical Research Consultants, Inc. provides consulting services in the fields of regulatory affairs (IDE, PMA, 510K, FDA), clinical trials management, quality systems regulations and management, manufacturing systems, operations, and strategic planning as they relate to research and development of medical devices and related technology. The consultants at Clinical Research Consultants, Inc. each have extensive experience in their respective fields of pharmacy, medical devices, engineering, business operations, and venture capital funding. CRC’s services include strategic planning, preparation of regulatory submissions, clinical trial design, study management, monitoring, statistical analysis for both pre-market and post-market studies, and design, implementation and assessment of quality assurance systems to ensure compliance to US FDA GMP regulations, ISO standards, and European Union quality requirements.

Compliance Insight, Inc.

Scott Gray — Sun, 02 Jul 2023 16:14:39 +0000

Compliance Insight is an experienced consulting firm capable of supporting a wide array of short and long term compliance activities. Compliance Insight specializes in regulatory and quality assurance consulting and training for pharmaceutical, chemical, bio-technology and nutraceutical companies. Compliance Insight offers GMP consulting, audit preparation, mock FDA inspections, FDA response assistance, vendor/contractor audits, new construction compliance, and nutraceutical compliance. Compliance Insight also offers training and education in the filed of quality assurance.

Eagle Certification Group

Scott Gray — Sun, 02 Jul 2023 16:17:21 +0000

EAGLE Certification Group is an accredited certification body offering third-party auditing services against ISO and GFSI standards. EAGLE engages industry-specific auditors to bring value to the companies they audit by offering constructive feedback for continuous improvement. EAGLE offers auditing services for certification to the ISO 13485 standard for manufacturing medical devices. ISO 13485 is an internationally recognized standard that helps medical device manufacturers and suppliers improve their FDA and regulatory compliance. It focuses on what the manufacturer does to deliver safe and effective medical devices. It is based off of ISO 9001, with an emphasis on maintaining system effectiveness and monitoring customer feedback.