GBA Key2Compliance supports BOHUS with comprehensive CRO services

October 18, 2024
Two persons working in a clean-room for medicinal production

GBA Key2Compliance Enhances Quality Assurance, Regulatory Compliance, and Clinical Investigation for BOHUS

At GBA Key2Compliance, we take pride in our role as the primary CRO for BOHUS, a Swedish company dedicated to producing high-quality hyaluronic acid (HA) products. Specializing in ophthalmics, aesthetics, and orthopedics, BOHUS extends its market reach to over 60 countries in the EU and MENA regions. Their commitment to excellence in HA manufacturing aims to revolutionize the market with superior products and sustainable processes.

Comprehensive CRO Support for Clinical Regulatory Excellence

To reach their ambitious goals, BOHUS relies on GBA Key2Compliance for expert guidance in regulatory compliance, quality assurance, and clinical investigations. Our partnership is instrumental in maintaining their high standards and ensuring products meet international regulatory and safety requirements.

Michelle Johansson, Head of Quality Assurance and Regulatory Affairs at BOHUS, emphasizes:

Michelle Johansson

GBA Key2Compliance is our main consultant in the clinical development process. They assist in developing the clinical strategy for our product portfolio, manage details in the specific study design, develops clinical investigation plans, and of course provides general clinical regulatory advice. All in all, they project manage all our clinical investigations from start to finish.”

Ensuring Regulatory Compliance for BOHUS’s Products

Our expertise supports BOHUS in manufacturing and delivering HA products across three primary areas:

  • Ophthalmics: Minivisc® Plus, an ophthalmic viscosurgical device (OVD), offers comfort and easy removal with high molecular weight and viscosity for optimum space during cataract surgery.
  • Aesthetics: The Decoria® dermal filler collection, featuring minimal HA molecule modification. The portfolio consists of four fillers: Decoria® Essence, Decoria® Intense, Decoria® Voluma, and Decoria® Intense Strong.
  • Orthopedics: Lubravisc® Bio, used in treating osteoarthritis, mimics and replaces naturally occurring HA, lubricating, and protecting cells and tissues.

GBA Key2Compliance ensures these medical devices meet regulatory requirements, providing support throughout the product lifecycle, including post-market surveillance.

Bohus Hyaluronic acid sample

Navigating Regulatory Changes

The introduction of the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) has increased regulatory requirements in Europe. GBA Key2Compliance has been instrumental in helping BOHUS update their documentation to maintain compliance with these stringent standards.

Synergistic Approach to Quality and Compliance

While BOHUS has a robust regulatory affairs and quality assurance department, the expertise and support from GBA Key2Compliance have proven invaluable. By partnering with GBA Key2Compliance, BOHUS ensures adherence to their quality management systems and internal procedures, while staying updated with ISO standards.

Michelle Johansson appreciates GBA Key2Complaince’s professional approach:
“They speak their mind without judgment and respect our decisions. Their competence and flexibility have made them a reliable partner for many years. They genuinely aim to offer the best solutions.”

Jeanette Demorney, Director of Clinical Development at GBA Key2Compliance, adds:

Jeanette Demorney, Director, Clinical development

We’ve been teaming up with BOHUS for several years now, and in that time, both our companies have grown. It’s truly a rare and invaluable privilege to have such a close partnership, allowing us to collaborate and support each other in meaningful ways.

Navigating the complexities of product development as a MedTech company is no walk in the park. It’s crucial to understand and adapt to each company’s unique ecosystem and needs. At GBA Key2Compliance, those of us in clinical development are driven by the potential of the products and the companies we work with, guided by our ethical compass and the regulations in place to ensure everyone who interacts with the product feels safe.

Plus, let’s be honest, we just enjoy working together. Our team meets every week, moving each study forward step by step. This is what we call the rewarding outcome of a ‘long-term relationship.”

Clinical Research Organization (CRO) Services by GBA Key2Compliance

GBA Key2Compliance offers comprehensive MedTech CRO services to support every step of your product’s clinical development lifecycle. We assist with clinical evaluations, study design, clinical investigations, and evaluations for both existing and new products. Our services include preparing for submission to competent authorities, assisting in handling the application process, and project management throughout the study conduct, closure, and incorporation of all collected data into the clinical evaluation.

Our team of experts ensures that your clinical investigation is conducted in accordance with the highest standards, providing robust data to support regulatory submissions and market access. Whether you are developing new medical devices or improving existing ones, our CRO services are tailored to meet your specific needs and ensure successful outcomes.

Partnering for Regulatory Success

At GBA Key2Compliance, we are committed to helping our clients achieve their regulatory compliance goals. Our team of consultants and industry experts offers tailored guidance, from medical device QA and regulatory affairs to clinical and product development. We also provide comprehensive training programs, including in-house, on-demand, and public courses.

Let GBA Key2Compliance be your full-service partner, providing the expertise and guidance you need to succeed. Contact us today to learn how we can add value to your projects and help you achieve your goals.

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