Founded in 2010, N&CS Consulting Group has quickly become one of Puerto Rico’s leading providers for computer systems validation and engineering to the life science industry. Its founder and president, Néstor Cardona, traces the evolution of N&CS over the last five years provides his outlook on the current state of the Puerto Rican manufacturing sector.
What is your assessment of Puerto Rico’s current environment for the life sciences industry?
The prowess of Puerto Rico’s life sciences sector is smaller than in previous years, but it is nevertheless growing. Puerto Rico has excellent talent, particularly in engineering. We train new recruits that have been recently graduated from university for all the consulting jobs required in the pharmaceutical industry. The industry today is focused on more than just being efficient; we need to reduce energy and utilities costs to be competitive and thus we are looking forward to energy-efficient projects. Currently there are a lot of validation remediation projects in Puerto Rico. N&CS specializes in performing Validation GAP assessments to determine if their current process and equipment are GMP-compliant. We perform those GAP assessments and recommend some feasible solutions to the industry to improve their manufacturing processes. The FDA is becoming increasingly aggressive, constantly auditing the regulated industries against compliance, and from those observations we help the clients.
How bad is the remediation situation in Puerto Rico?
The issue is that much of Puerto Rico’s engineering talent is departing for the US for economic reasons. In terms of the resources that are needed for the remediation corrective actions, companies must engage in an extensive interview process to get the right people for the job. Therefore, this mass exodus of people leaving Puerto Rico creates many challenges in terms of trying to find the right person to do the right job. Most consultancies in Puerto Rico are trying to help each other by engaging in a temporary partnership to cover the needs for the specific projects.
Is the fact that companies need those services a direct consequence of people leaving Puerto Rico?
Puerto Rico has many engineers emerging from its various universities, but there is indeed a lot of talent leaving. When we look for new resources with experience (these jobs require lots of experience), either we train such individuals or send them to an academy, or we look for people with specific skills or professional background for the job. Momentarily it is challenging to find the right resources to do a job, specifically big compliance remediation projects that require hundreds of people. As a responsible company we look forward to providing them the right resources tailored for the specific tasks.
Where do you see Puerto Rico as a competitive player worldwide in terms of manufacturing, given the emergence of countries like Ireland and Singapore as competitive countries too?
I think there is a difference between what is happening in Ireland versus Puerto Rico. Puerto Rico has lots of manufacturing experience, not just at a technical or executive level, but more generally speaking. The Puerto Rico government provides more tax advantages to lure more new companies to manufacture in Puerto Rico. While many companies are going to Singapore having learned from the Puerto Ricans, this country has an immensely strategic location. Being in the middle of the Caribbean provides us with a business advantage in terms of transportation and logistics for business in Europe and across the Americas.
You founded N&CS and have nurtured its growth over the last five years. What was the inspiration for creating this company?
Our mission is to recommend the best practical approach solution for any health industry need, having as baseline full regulatory compliance while maintaining low implementation costs. By providing excellent validation services, we engage in a direct connection with the health of the end customer, we assure that the quality of the product is at its best. The lives that are saved, improved and healed are our everyday inspiration!
I graduated as a computer engineer from the University of Puerto Rico, and I am an expert on computer systems validation. Our first projects were more related to this as I was the only person working in the company. After that we integrated more people to become an even more efficient company. The quality of our job has been our best presentation letter. We are celebrating our fifth anniversary in 2015 and are handling projects of about $5-6 million per year. Our reputation has quickly become well-known throughout the country.
Puerto Rico is already saturated with so many other companies doing similar work. What was it about N&CS that allowed you to stand out?
It is our economic competitiveness. N&CS tailors its services based on client requirements to provide exactly what they need. That requires extensive planning and assessment. We look objectively to the problem and propose a solution while maintaining project schedule. We look for resources that require less time to learn about the process that we are actually performing and consequently work more efficiently. We have a reputation for always finishing the job on-time and on budget, and that is why companies prefer N&CS.
Many companies seem to have developed their business based on a specific niche, usually the expertise of the founder, and if certain elements within that expertise are missing you can partner with another local service provider.
Indeed; we help each other. We have expertise in some areas while other companies have expertise in other areas, so we form partnerships between companies. For example, N&CS has expertise on computerized system validation, equipment and utilities validations, and we have engaged partnerships effectively with other companies to provide a wider range of GxP compliance solutions.
N&CS offers a number of services in validation, documentation, automation, among others. Where do you generally find your clients need the most help?
Customers are frequently requesting validation services, especially in manufacturing and packaging equipment. Process and manufacturing engineers needs support, and contract engineers for process improvement projects. Our clients also request automation and integration of process equipment and utilities using computerized systems and building management systems.
What is your international expansion strategy?
N&CS opened an office in Georgia through the Georgia Foreign Corporation Certificate of Authority in February 2015. Our expansion plan involves the provision of services to the US in Georgia, Florida and Texas as well. As there are many experienced people with the talent required to do the job but are wishing to leave the country, the premise of our expansion is based on the fact that we want to provide these experienced people the opportunity to go to the US and continue their careers there. As such we should seize the opportunity to do regulatory compliance projects there.
The reputation that Puerto Ricans have abroad from the life sciences perspective is very positive.
In the US, many executive positions in the pharmaceutical industry are held by Puerto Ricans. With everything happening right now, Puerto Rico is still in a healthy environment for the pharmaceutical industry. Production in Puerto Rico is still immense, and it is because we do it well here. Other countries with production often face many issues that involve much remediation, which is not valuable.
What do you feel is N&CS’s part in the collective responsibility of Puerto Rican companies to promote the country to the rest of the world, especially as local companies start to go abroad?
In the following years, manufacturing companies will continue to do business in the island for the tax advantages. The current evolution is positive, as we are merging with other companies to provide the right support in Puerto Rico, and also because companies are expanding to other countries themselves with the same services. N&Cs is engaged in providing our expert consultant advice for companies all over the world, our current technologies provide us with the tools required to provide the professional services without leaving the island. The way consulting jobs are performed is evolving as we would normally do business. We can perform the jobs from here, helping the Puerto Rican economy, but sharing our expertise with the rest of the world.
Where can we expect to find N&CS by 2020?
We will be continuing our impeccable work here and in the US, with remarkable integrity, providing services to all the companies here to avoid further observations from regulatory agencies. Every company should do its manufacturing the right way and in compliance with regulatory agencies, and we will pursue to accomplish this. I would also like to see new product research and development facilities from the very talented and prepared students emerged from the Universities of Puerto Rico, and demonstrate to the rest of the world our commitment to a better and healthy life.