Advisory & Regulatory
Clinilabs Drug Development Corporation provides advisory services that merge our therapeutic area and commercial expertise to support global CNS drug development programs and drug lifecycle management. We combine our scientific and operational understanding of CNS drug development with our knowledge of healthcare delivery to help our customers launch products with the greatest potential for commercial success.  We merge our senior advisors with external (consulting) subject matter experts to create advisory teams able to get to the heart of our customer needs. We offer perspectives from a diverse panel of individuals from industry, academia, and clinical medicine to offer customers actionable insights and solutions. Through the strength of our personalized approach, we provide the resources to develop strategic approaches to asset development.
Regulatory services are among the most important elements of support needed by small- to mid-sized drug companies. Clinilabs works with trusted partners worldwide to support clinical and regulatory activities in the U.S., European Union, and emerging markets. This includes regulatory guidance for the development of new chemical entities, the execution of multinational clinical trials, and the evaluation of previously marketed products. The expertise we provide in CNS therapeutics enables our customers to make informed decisions regarding drug development plans and regional applications for marketing drug products. The teams we assemble have extensive experience in multinational filings, offering a competitive benefit to customers who do not have in-house regulatory functions. We are pleased to offer second opinions regarding regulatory matters.
Protocol design and program development
Clinilabs maintains a Scientific Advisory Board that is prepared to provide protocol development and program development advice to sponsors. The members of our SAB are subject-matter experts who are highly regarded in their respective fields, and many are considered key opinion leaders (KoLs). Our advisors enable us to deliver scientific advice to sponsors developing drugs in the CNS therapeutic area.
IND Applications and Translational medicine
Clinilabs maintains relationships with a small group of advisors who have expertise in translational medicine. These individuals evaluate pre-clinical data to assist in the development of IND applications, investigator brochures, and clinical development programs.
Regulatory Services
Clinilabs provides support for the development of INDs, as well as regulatory filings in the EU.
Advances in drug development have led to greater improvement in the quality of human life than advances in all other fields combined.
Drugs don’t work in patients who don’t take them.
Without drugs, physicians would struggle to find relevance, and patients would suffer without hope.
It is easy to get a thousand prescriptions, but hard to get one single remedy.
The cures we want aren’t going to fall from the sky. We have to get ladders and climb up and get them.
I must say, I spend a lot of my time these days trying to persuade people that controlled trials are the only way to get information that’s reliable about drugs.
I trust I may be enabled in the treatment of patients always to act with a single eye to their good.
The reward for work well done is the opportunity to do more.
All truths are easy to understand once they are discovered; the point is to discover them.
If you think compliance is expensive, try non-compliance.
One never notices what has been done; one can only see what remains to be done.
One sometimes finds what one is not looking for.
Remember the Three Princes of Serendip who went out looking for treasure? They didn’t find what they were looking for, but they kept finding things just as valuable. That’s serendipity, and our business [drugs] is full of it.
I am not accustomed to saying anything with certainty after only one or two observations.
There is so much more to be done; the patients are waiting.
The best way to predict the future is to invent it.
The pace of discovery is going unbelievably fast.
The greatest joy in life is to accomplish. It is the getting, not the having. It is the giving, not the keeping.
Good information is the best medicine.
Let me tell you the secret that has led me to my goal. My strength lies solely in my tenacity.
I have no ideology. My ideology is health.