Change is constant
in a world in continuous transformation
Today the health industry faces great scientific, technological, and social challenges. In terms of regulation, the challenges are not few.
The stringent and variable demands of regulatory agencies in Mexico and Latin America are laborious and tiresome if inadequately addressed.
At Udelá we keep ourselves updated, ready to face the demands of a world in continuous transformation.
ADDRESS NEW CHALLENGES THAT GENERATE PROFIT
Medicine, science, and technology today live their golden age. Human beings benefit from progress, without a doubt, this is the best time to live.
And that is because there are visionary companies and teams. With a great desire to tackle new challenges, expand its business reach, and build a world of health and wellness opportunities.
That is why you are reading this, because you can see opportunities for growth, and you want to go one step further.
WE SPEAK THE SAME LANGUAGE
At Udelá we know that success in regulatory matters is built on good chemistry between the parties involved: our clients, the regulatory agencies and ourselves.
We function as a bridge for understanding. We speak the same language.
We understand the needs of our clients, we know closely and familiarly the regulatory scheme of the jurisdiction to which you wish to enter.
Our goal is to ensure faster execution in your process. We perform accurately and sensibly.
A UNKNOWN NEW PROCEDURE
On many occasions, companies and their teams face new procedures; they are in unknown territory and full of doubts.
Let’s be honest, it’s impossible to know everything; For this reason, at Udelá, we have a wide range of services that will help you solve your problems.
Agility in your regulation
Processes with long and unnecessary deadlines create delays for your company to guarantee access to equipment, products, and medications.
In the world there are patients whose life depends on a medicine or a medical device. Yes, the one that you and your team have researched and developed.
Regulatory standards always undergo changes and modifications, that is why the importance of keeping ourselves updated and constantly learning.
The answer from the authority never came
It is likely that you have had bad experiences or problems with the various regulatory agencies.
Does your regulatory team have little experience in the market you want to enter, does not know the regulation of the country and spanish is not your native language?
All regulations in Mexico and Latin America are written in Spanish (except for Brazil).
Did you start the regulatory process and submitted all the documentation that was required; your team checked it several times and it seemed to be in order?
Did you wait for a response within the period set by the authority? but there was no response.
What did you do wrong? Was there any document missing? Was the department you directed the information the right one?
Did you start your process on time and did your regulatory team think that the documentation was correct?
A few days later, they received a warning from the authority. Its regulatory team responded to the document inadequately.
Therefore, the process was delayed due to the cancellation of the sanitary registration and security measures were applied that prevented continuity.
The notification of preventions is the most normal, you just must know how to respond at the right time.
These are the kinds of problems that arise when blindly entering the arena of complex regulatory agencies. We see it every day.
These situations are a waste of time and resources. They are headaches.
KNOW HOW TO RESPOND AT THE RIGHT TIME
A ROBUST AND WELL-TRAINED TEAM
There are big and complicated documents that need to be approached in a methodical way to be successful, and teams don’t have time.
Companies that have robust and well-trained regulatory teams can ensure complex submissions correctly and quickly.
At Udelá we understand the difficulties that a company faces on its regulatory path.
For a long period, we work for the agencies of the countries where we have a presence.
We discovered that the authorities did not have the necessary knowledge to interpret the regulatory issues of companies that wanted to enter the market.
Whether by the company or the agency, sometimes there is no understanding of what is requested or required, there is a lack of precision.
At Udelá we understand the language and the needs of both the industry and the regulators that supervise it.
We are a bridge
between you and the agencies
Our commitment is to empower your team and provide you with information in a friendly way, no matter what language you speak.
We offer you a vision
Of the different factors and of the technical, scientific, regulatory elements, of the regions that affect the access of the products.
We design strategies
Tailor-made for the approval and introduction of products to the markets.
The continuity of your product and that your business is profitable.
We provide tools
That prepare your team to receive inspections from the different regulatory agencies.
We support in the implementation
Good practices in your facilities.
We function as your legal representative
So, you can market your products.
Get to know us
through the opinions of our customers
With great pleasure, I highly recommend the company Intelligence in Regulatory Solutions S.A. of C.V. (Udelá), which has demonstrated ethics, experience, professionalism, and quality in all the projects we have shared.
Director of Clinical Operations
Consulting firm and CRO specialized in research and pharmaceuticals in Mexico
I would like to highly recommend the company Intelligence in Regulatory Solutions S.A. of C.V. (Udela)
During the 3 years that he has collaborated with us, they has always demonstrated a high level of professionalism, dedication, excellence and mastery on the subject in all the projects we have developed.
Director of Operations and Business
Pharmaceutical company with more than 15 years of experience
I highly recommend the company “Intelligence in Regulatory Solutions S.A. of C.V.”
They have demonstrated high standards of professionalism, experience, and quality in all the projects that have been entrusted with.
Mexican company dedicated to the development, manufacture, and marketing of quality pharmaceutical products
It is possible that you are not interested in creating a company in Mexico or in LATAM, but the market attracts you and you are looking for a strategic ally.
Fill the next data and we will contact you in order to bring you further information.