Optimizing results in pharmaceutical industry
Simplify your regulatory management and boost your productivity.
About us
Our team assists biopharmaceutical and medical technology companies in managing regulatory information to increase productivity and efficiency.
We provide regulatory solutions supported by an experienced team, in relation to customized needs and responsive competence throughout the steps of pharmaceutical development.
We advise, develop, review and provide support for the creation of documentation for drug registration purposes across different stages, observing product’s safety and efficacy evidence. Our scope of work includes synthetic and semi-synthetics drugs, radiopharmaceuticals, biologics, and biotechnological products, among others. We assist throughout the entire product lifecycle: from early drug development to submissions, registration and post-marketing monitoring.
The outcome of our services enables decision-making with upper possibility of success, risk mitigation and proactive problem-solving.
Let us attend you on a timely, agile, and efficient journey.
Our specialized team maximizes the productivity and efficiency of your biopharmaceutical company, offering solutions adapted to each stage of your product development.
Our services
Composition of dossiers in CTD format according to international standards (ICH)
Submission of dossiers for any purpose
Search for national and international information
Drug safety updates
Clinical review of therapeutic indications
Documents development for compliance with Good Practices (GxP)
Pharmacovigilance systems audits
Elaboration, supervision and review of risk management plans
Design and analysis of bioequivalence studies
Documents for design, development and execution of clinical trials
Why choose us?
Proven Expertise
We have vast experience in the biopharmaceutical and health technology industry, guaranteeing precise and effective regulatory solutions.
Integral adviser
We offer complete support in all phases of drug development and registration, ensuring efficient and smooth management.
Unique approach
We customize our strategies to the specific needs of your project, providing tailored solutions that optimize productivity and minimize risks.
Coverage
We provide support throughout the entire product life cycle, from initial development to post-registration monitoring, ensuring ongoing regulatory compliance and the success of your products in the market.
Transform your regulatory management
Specialized support with extensive experience of success.
Office in Miami
Phone: +1 (786) 650 4440
Mail: info@phexkno.com
This website has been originally written in English. Any translation into other languages is made automatically.