Caderso
A Go-To Place for Regulatory Strategy and Government Audits

Navigating regulatory compliance can be tricky for pharmaceutical companies. Mexico has recently joined an international regulatory body, and there’s a concerted effort among them to align with international standards in the pharmaceutical sector. Companies are looking for the right balance between competitive pricing and investment in re-engineering processes and quality systems. It’s a tough road ahead as they aim to expand into new markets, especially Europe and the U.S.

In the medical device sector, recent updates in regulatory compliance have significantly elevated its standards, mirroring a more stringent approach akin to the FDA standards. This regulatory change has prompted manufacturers to grapple with initiating projects while keeping up with new regulatory measures. Given this scenario, drug and medical device manufacturers necessitate assistance to comply with industry regulations, make judicious infrastructure investments, operational strategies, and maintain cost-effective operations. This is where CADERSO—a regulatory affairs and project management specialist within the pharmaceutical industry—becomes relevant.

“We strive to establish ourselves as a pivotal ally for national and international pharmaceutical companies, offering expertise in investment approach, regulatory strategy, and government audits. While accomplishing this, we ensure the seamless adoption of industry best practices,” says Emmanuel Gonzalez, CEO of CADERSO. The company achieves this objective through meticulous quality control and maintenance of current regulatory compliance standards.

Pillars of Service Portfolio

CADERSO’s comprehensive suite of services comprises two key areas. The first is regulatory audits, a fundamental requirement imposed by regulatory bodies globally. These audits, occurring at least twice a year, cover both internal operations and external providers.

The more dynamic aspect of CADERSO’s services lies in project consulting. Whether clients are establishing new pharmaceutical lines, exploring novel avenues, or enhancing existing products, its consulting approach involves tailoring projects to address their instant needs by studying their immediate, medium-term, and long-term objectives. This could be enhancing regulatory compliance, updating quality systems, or digitalizing operations. The company re-engineers R&D processes, operational flows, and contributes to enhancing quality systems. Whether it’s a reinvention of existing systems or the creation of a quality system from scratch, CADERSO covers every aspect related to quality systems in the pharmaceutical and medical devices sector.

CADERSO assists clients with product re-registration and offers support in the layout design for new areas.

Enduring Partnerships with Clients

At the onset of the client engagement process, CADERSO takes the time to understand client’s requirements, whether they focus on their growth or process automation. It then develops a strategy aligned with their objectives for the year. For goals like operational excellence, the company creates a detailed project plan with activities, responsibilities, and a timeframe. Depending on the contracted service, it offers hands-on consultancy or periodic audits to ensure correct implementation. It is very stringent with completing projects within the agreed timeframe, without scope changes. CADERSO considers itself as a partner rather than just a service provider, empathizing with clients’ challenges. Its solutions have garnered appreciation, fostering long-term relationships. Its priority to comprehend clients’ objectives prior proposing strategies and the collaborative approach has led to enduring partnerships. CADERSO further interacts with client company’s quality directors and leaders at least once a month.

“The regular interaction fosters a continuous exchange of feedback, ensuring a dynamic flow of information. We actively seek feedback from clients, which enables us to enhance our services based on their valuable insights,” says Gonzalez.

The company’s government-focused team keeps itself updated on regulating laws and norms. Clients can proactively plan for and adapt to upcoming changes, minimizing potential issues and ensuring compliance in advance, by taking forward-looking information from CADERSO.

Marking Significant Milestones in Mexico

In one instance, CADERSO collaborated with a leading generics pharmaceutical company in Mexico. It assisted them in crafting a strategic plan for establishing their R&D facility, now set to become the largest in Mexico. Upon completion, this facility will not only serve the domestic market but also position the company to cater to Latin American and U.S. markets. This project marks a milestone in Mexico, and CADERSO is proud to announce that it is approaching the project’s successful conclusion later this year.

This greatly contributed to serving the Mexican population in need. CADERSO’s expertise extends beyond drug manufacturing to encompass compounding, excluding hospitals from its service offerings. In another case, CADERSO helped a client with a compounding service who faced several challenges and opted to overhaul all their compounding sites. In response, CADERSO developed new quality system documentation and designed a generic layout akin to a McDonald’s model—easily replicable based on the premises. The process took about one and a half years, resulting in the successful opening of 12 additional compounding sites, despite closing two. Upon project completion, they had a total of 15 operational sites, all compliant with the health ministry regulations. This greatly contributed to serving the Mexican population in need. CADERSO’s expertise extends beyond drug manufacturing to encompass compounding, excluding hospitals from its service offerings.

The Team’s Contribution to Delivering on Promises

CADERSO’s operations team comprises 42 experts, led by three directors, each specializing in the pharma sector, medical devices, and R&D. It has another director overseeing administrative and business aspects. Having a leader dedicated to the business cabin allows it to guide clients through quality compliance without overlooking the financial and revenue implications.

“Our key differentiating factor lies in the human capital resources. The team is meticulously curated, comprising individuals with substantial experience, many of whom have served in the health ministry or are retired directors from prominent pharmaceutical industries in Mexico,” says Gonzalez. The company takes pride in the wealth of knowledge each team member brings, ensuring that clients receive expert guidance and support.

In its approach to helping clients comprehend regulatory requirements, CADERSO offers comprehensive training sessions, covering both theoretical aspects and practical exercises. This ensures a hands-on understanding of the subject matter. Whether it’s training for new regulations or processes being implemented by clients, the company tailors its programs for each client. These sessions typically span 1 to 5 days and are customizable based on client needs. This allows employees to feel secure in their knowledge, ensuring they can seamlessly apply learnings to their jobs while staying compliant with established processes.

Present and Future Endeavors

CADERSO’s current emphasis is to establish a partnership with a prominent university in Mexico. It intends to work in tandem with the university to develop a comprehensive framework and platform. This will empower students and recent graduates, providing them with a competitive edge in pharma industry consulting.

It is also building up its team to include experts specializing in diverse markets, particularly in Latin America and the U.S. This ensures that it is well-prepared for the upcoming stages of its expansion. Alongside, CADERSO is focusing on integrating AI in regulatory compliance consulting. Although it is at a nascent stage, the company’s aspirations include the possibility of offering impactful solutions to clients by harnessing the potential of this cutting-edge tool. It hopes to successfully deliver innovative solutions tailored to leveraging the power of AI.

“Drawing from half a century of expertise and partnering with industry giants, we are committed to upholding the stringent compliance standards required by sanitary regulations and applicable laws in both Mexico and globally,” says Gonzalez.