PHARMA-BIO SERV.
THE COMPANY’S EXPERIENCE
Pharma-Bio Serv was founded in 1993 to provide services to the pharmaceu cal industry related to process and technology transfer, as well as process valida on. It later expanded its horizons to provide regulatory compliance services not only to the pharmaceu cal industry but also to the medical device industry and FDA-regulated industries in general.
Our services con nued to grow to offer all types of qualifica ons, valida ons, training, compliance or remedia on prepara on, and regulatory affairs aswell. We have grown to a team of over 250 employees and associates, based in several countries. We are an interna onal company, expor ng our knowledge acquired in Puerto Rico to now more than 30 countries around the globe.
I am from Zaragoza, Spain, where I started my career in Chemistry. For personal reasons I came to Puerto Rico in 1995, where I finished my studies as a chemist, then I got an MBA in Industrial Management at BBVA which helped me to have a technical-scien fic perspec ve of the industry and allowed me to understand business. Shortly a er arriving, I started working in a pharmaceu cal company. I was in this leading manufacturing plant un l 2005 when the company decided to send me to Spain. There I took over the opera ons of the pharmaceu cal plant and got to know Pharma-Bio Serv's capabili es as a client. Beyond my studies, the experience was my best university. I never stopped studying, I did another master's degree at the Dublin Ins tute of Technology and obtained a cer fica on in US regulatory affairs also.
ACHIEVEMENTS
We were among the first service companies to serve companies manufacturing in advanced therapy areas for the U.S. The best prac ce regula ons for those products were being wri en at the same me we were defining expecta ons to help those companies. We had the opportunity to support stem cell ins tu ons that were star ng to manufacture for the U.S.
At the plant of one of our customers, I had the opportunity to personally meet a pa ent who had par ally recovered from complete paralysis and who arrived walking with a cane thanks to the therapies he had received. When you see things like that the personal sa sfac on is much greater than when you get mul -million-dollar projects.
Ul mately what we do is to help people, so our work is par cularly important to our clients and their pa ents. From a personal point of view, it is very gra fying.
THE PHARMACEUTICAL SECTOR IS GROWING BY 20% IN PUERTO RICO, IT IS NUMBER 7 IN WORLD PRODUCTION AND ACCOUNTS FOR 25% OF THE COUNTRY'S GDP, BUT IT HAS STAGNATED A LITTLE LATELY. HOW DO YOU SEE THE FUTURE OF THIS SECTOR?
Puerto Rico con nues to be one of the most favored pla orms for drug manufacturing in the world and it is not only because of tax exemp ons since it has an excep
onally good pharmaceu cal infrastructure.
When you compare it to other jurisdic ons you see that over the years it has created an immensely powerful network of service and raw material suppliers and the installed manufacturing capacity is magnificent. All this in a jurisdic on that operates under U.S. law, which provides security and stability.
But the most a rac ve thing about Puerto Rico is that there are very well-trained human resources with solid knowledge, unbeatable when compared to other places, at a very reasonable cost. Here it is very easy to find all types of workers, from operators, technicians, supervisors, to management, all specialized technical personnel with a deep understanding of pharmaceu cal regula
ons.
Although there is s ll a long way to go, several universi
es in Puerto Rico and especially the Mayagüez campus of the University of Puerto Rico have specific programs for the pharmaceu cal and medical device industry in careers such as Chemical Engineering, which con nues to make this human capital con nue to have a spectacular value.
Finally, the resilience of our people and our industry. When Hurricane Maria surprised us and prac cally destroyed the island, the industry was shocked and worried about the stoppage it would mean in the manufacturing of products. The truth is that, in most cases, within a few days many plants were already opera ng. Puerto Rico has created that resilience and a rac veness for the pharmaceu cal industry that will allow health industries to con nue to grow.
We are part of their territory and work under FDA regula ons. The FDA office district in San Juan has been at the forefront because of the knowledge gained from the number of inspec ons performed, which surpassed larger territories. It is the same with Puerto Rican workers who have high levels of knowledge of the FDA and its regula ons, it is a symbiosis. The industry learns from the regulators and vice versa. Experience is paramount for us and one of the compe -
ve differences for our company, when it goes outside the U.S., is our knowledge of FDA regula ons and expecta ons. Many of our customers in Europe, Asia, and La n America require us for that knowledge, it has been cri cal to be here. From a business standpoint, our sales in the con nental U.S. represent approximately 10%. There is s ll a lot of room to explore in the U.S. and part of our strategy last year was to grow there and we have already started to create a structure to support that growth. Our business is growing because of recommenda ons from our customers themselves.
We are developing alliances and agreements in the U.S. and we con nue to evaluate our infrastructure to achieve a higher percentage of the business.
HOW DO YOU GAIN RECOGNITION IN A MARKET LIKE THE U.S.?
By doing things right. Every project is different, and some are especially cri cal, some mes we get fully involved and in others, we just par cipate in a part of the project, but we are always a en ve to the quality of our service. The founda on of any company is its employees.
Throughout our history, we have obtained more than 50
thousand references of professionals who are in our database. request for a project, we evaluate the needs based on what the client communicates to us and with our knowledge of the business. That connec on with the client and that demonstra on of knowledge of what we are doing create trust.
EXPANSION IN LATIN AMERICA
In 2015 we established an office in São Paulo, Brazil. We work for the two most important Brazilian branded drug companies in the country; we are helping them in different areas. One of the difficul es has been ge ng the right human resource because not everyone has worked in the pharmaceu cal industry regulated by the FDA. On the other hand, the currency exchange rate between the dollar and the Real has slowed our entry. We have requests from Mexico, especially because during the pandemic it has received a lot of scru ny from the FDA regarding pharmaceu cals. We have also worked with the food industry in La n America, which is strong and growing.
We con nue to work regularly for the industry in Panama and Costa Rica. Our strategy is to con nue to grow in those countries, although we are not a mega-company that can invest 5 million by opening offices in many places nor do we need to, every me we receive a project, we make sure we give an efficient service so that we are recognized as the best company that knows the FDA in-depth, that they can communicate in Spanish and that can solve their regulatory and compliance issues.
WHAT IS THE IMPORTANCE FOR THE COMPANY IN THE U.S.A. AND IN EUROPE AND LATIN AMERICA WHAT EXPANSION PLANS DO YOU HAVE IN MIND IN THE MEDIUM AND LONG TERM?
FINAL MESSAGE
We have been experiencing growth for 28 years, except for very few months in our history, which demonstrates that we have been doing something right. We know the formula: offer the best knowledge efficiently and flexibly, and we have the experience and the pla orm to con nue that growth and expand. Our market is one of the most dynamic and one of those that contribute the most to society, which is not only a great opportunity but also a source of sa sfac on.
We will con nue to grow and add value to our investors, our employees, and our customers. We believe that if we bring value to our employees, they bring value to our customers. Our customers can rely on our services because they are quality. While other companies may have more brand recogni on, we can do the same and even reach places they do not. The quality/price ra o of our services is unbeatable.
I hope that everyone: clients, investors, and employees, will con nue to bet on our company. We will con nue to do our best to serve our customers sa sfactorily.