Sobel Consultancy
Winning in Highly Regulated Markets

Bringing a medical device to market is not a straight path from innovation to approval. It’s shaped by shifting global frameworks, compressed timelines and exacting regulatory demands. For most companies, this creates familiar tension; internal teams drive for speed while regulators urge caution. In that push-and-pull, progress is often at risk.

That’s where Sobel Consultancy comes in—not just as a regulatory expert, but as a true strategic partner, helping companies stay focused, aligned and on course when the stakes are highest.

Clients turn to Sobel for direction that helps them know when to press ahead, when to pause and how to make those decisions in line with the bigger business picture. Turning every regulatory complexity into progress and pressure into purpose has enabled Sobel to earn its place in the niche.

“We’re constantly balancing two forces,” says Maik Endler, founder and CEO. “Clients want efficiency, speed and clarity. Regulators require precision, process and accountability. Our job is to reconcile both without compromise.”

Sobel weaves compliance into the core of the business. Whether a device needs to hit an aggressive market window, a submission faces shifting EU MDR expectations or a global launch strategy outpaces internal regulatory capacity, it creates the infrastructure needed for sustainable, scalable growth.

That can never happen by relying on standardized checklists. Sobel contextualizes. It analyzes each guidance document in technical depth and applies it in ways specific to the product, the market and the stages of development. Sobel works directly with regulators as collaborators, not gatekeepers, and builds strategies that meet regulatory expectations and business objectives. With a combination of deep industry knowledge and an agile, case-by-case mindset, Sobel helps clients move forward with clarity. And where intelligent automation or AI-based tools can reduce errors and improve speed, Sobel integrates them, delivering compliance operations that are both rigorous and efficient.

For instance, leveraging proprietary processes and technology has dramatically accelerated complex tasks. Clinical evaluation reports that once took over a month can often be completed in one to two weeks.

As one of the top medical device regulatory consultants, Sobel’s value isn’t in visibility—it lives in outcomes. With experience across the U.S. FDA, EU MDR and other regulatory ecosystems, the firm is adept at designing multi-region strategies that balance harmonization with the specific nuances of each market. Sobel is the partner who sees what’s coming and builds compliance into the foundation.

A Vision Born from Industry Challenges

The firm was built on a deep understanding of the challenges in bringing medical devices to market. Maik Endler spent years in design, development, manufacturing and regulatory compliance. He saw firsthand how rising regulatory costs and complexity created significant barriers.

While leading a global consulting firm’s expansion into South America, he evaluated the broader regulatory landscape and identified a growing issue. Soaring demand for compliance expertise drove up costs in high-regulation markets like the U.S., Europe and China, making it increasingly difficult, especially for companies outside these regions, to navigate approvals efficiently.

This sparked an idea. What if world-class regulatory expertise could be delivered without the overhead tied to traditional markets? Brazil, with its strong regulatory system, skilled workforce and cost advantages, provided the perfect foundation. It enabled him to establish Sobel to deliver high-standard services while maintaining a more competitive cost structure.

For global companies, Sobel has become a cost-effective alternative to expensive firms dominating high-regulation regions. By offering local expertise with global reach, it eliminated the need for costly foreign consultants and became a gateway for Brazilian companies to expand internationally.

This cross-border capability proved invaluable when a Brazilian cosmetic company sought to enter the U.S. market. Facing strict safety requirements and limited budgets, the company needed a streamlined compliance strategy. Sobel guided them through complex evaluations, leveraging dual-market knowledge and digital-first workflows to ensure compliance while keeping costs manageable. The successful product launch that followed is a strong example of how targeted regulatory support can turn market-entry challenges into opportunities.

Where Strategy Meets Science

Sobel’s services—regulatory strategy, quality management, biological and clinical evaluations, submission processes and local representation—are designed to integrate seamlessly with the natural flow of product development.

From the outset, Sobel works with clients to craft a regulatory roadmap tailored to target markets. Identifying requirements early minimizes delays and unforeseen compliance challenges, enabling companies to confidently move forward.

Certification bodies demand structured, consistent processes to ensure product quality. With Sobel’s support, clients can implement and verify these processes, ensuring alignment with international standards. Whether building a compliance framework from scratch or refining existing protocols, the goal is to maintain operational efficiency while meeting strict regulatory expectations.

Many consulting firms in South America focus on submissions late in product development, but Sobel takes a strategic, upstream approach. It recognized early on that biological, toxicological and clinical evaluations are major pain points for manufacturers. These qualifications are rarely needed on a daily basis and are often absent in-house—yet they’re essential for demonstrating safety and performance.

To solve for this, Sobel deliberately integrated regulatory and clinical expertise at its core. One division specializes in regulatory compliance and quality management and another in biological and clinical evaluations, allowing the firm to support clients end-to-end, regardless of geography. This model ensures that companies, whether operating locally or preparing for global entry, receive seamless support, from development through approval, and the potential for last-minute obstacles is minimized.

That global capability has been critical in projects well beyond South America. When a German medical device company faced regulatory issues while attempting to get clinical trials approved in France, Sobel stepped in. The team partnered closely with the client and hospital, providing strategic clinical documentation and overcoming local regulatory obstacles. With the firm’s help, the client successfully initiated trials and advanced research in the French market.

Scaling Smarter and Removing Barriers to Market

After establishing itself in North America and Europe, the firm is deepening its presence to support more clients navigating complex approval processes. It’s also tackling a pervasive myth that world-class regulatory consulting must originate in traditional markets. Sobel disproves this with ISO 9001 certification, a global standard underscoring its commitment to quality and third-party accountability.

The growth is directed toward creating more efficient, integrated compliance. Companies often juggle multiple providers for different regulatory needs, resulting in fragmented workflows, higher costs and alignment issues. Sobel is closing this gap by expanding into clinical trial management, removing the need to coordinate between multiple partners from research to approval. It also bridges the gap between clinical research and regulatory approvals, often a source of costly misalignment. Internalizing trial management is creating a more direct path to compliance, accelerating approvals.

Sobel is also expanding its regulatory expertise into in vitro diagnostics and pharmaceutical industries with similarly rigorous requirements. Its foundation in biological evaluations, particularly in assessing how polymers, coatings and other structural components in cassettes, cartridges and microfluidic systems interact with the human body, makes this a natural progression. These materials can leach, degrade or interfere with diagnostic accuracy and must be evaluated for biocompatibility and performance, just as in traditional medical devices.

The same applies in pharmaceuticals, where evaluating the safety of active ingredients and excipients demands comparable scientific depth. While clinical trial management in pharmaceuticals is still in development, Sobel is actively preparing to offer this service, particularly within Brazil’s favorable regulatory environment. As expansion continues, clients will gain a trusted partner equipped to support diverse product categories with scientific and regulatory clarity.

At Sobel, growth is guided by intention and responsibility. Every potential service is evaluated through a critical, internal lens, focused on feasibility and whether it aligns with the firm’s broader commitment to sustainable, ethical impact. This principle led to a conscious decision to stay out of pesticide regulation. Despite market opportunity and relevant expertise, the area didn’t reflect Sobel’s vision for responsible industry contribution. It’s this kind of discernment that ensures the firm’s growth reflects long-term value for both its clients and the sectors it serves.

In a world where the cost of delay is steep and the price of misalignment even steeper, choosing the right partner is a strategic imperative. Sobel’s ‘more than compliance’ support delivers much-needed clarity, momentum and trust. For companies ready to scale smarter, move faster and enter markets with confidence, Sobel is not a consultancy. It’s a regulatory catalyst.