Pharmexon offers extensive technical gap analysis utilizing a wide variety of experience experts ensuring a knowledgeable and worthwhile investment. The experts use their many years in the industry to offer comprehensive, objective analysis given the client’s parameters and situation.
With extensive knowledge of regulatory requirements and general industry trends, the client can be confident that the advice and analysis offered is tailored to their specific needs, understanding the uncovered gaps and the methods to close them.
Pharmexon moves beyond simple analysis, rather also offering implementation support, giving the client timely advice through the entire process. Using Pharmexon, the client will uncover a clear path forward with experienced individuals with regulatory expertise by their side.
Through the eyes of experienced experts, Pharmexon offers extensive support related to regulatory due diligence and strategy.
These experts use their knowledge of the industry, including regulations, trends, and other factors to support the client in positioning themselves in the more advantageous position depending on their situation. The regulatory landscape is constantly changing, thus using Pharmexon reduces the risk of potential gaps in compliance or other issues due to the experts’ knowledge and support through the entire process.
The client can be confident that they are prepared to move forward knowing the support they have received and continue to receive.
Pharmexon offers comprehensive CTA (Clinical Trial Application) services, ensuring the client’s clinical trials are in regulatory compliance while also being put in the best position to receive ideal results.
The team works to advise clients from the very beginning, illustrating the documentation needed depending on the region, while also helping to prepare documentation such as Informed Consent Forms.
Pharmexon’s services move beyond documentation, however, with the team’s enhanced knowledge of the industry and the clinical field enabling them to advise clients on risk management, safety monitoring plans, while also considering quality assurance and compliance. Support of these trials can also include consultation regarding data management and statistical support, in addition to general project management.
Pharmexon offers extensive local representative services depending on the client’s situation and goals. The team can act as a regulatory liaison for the client, representing the client and handling contact between regulatory bodies such as the FDA or the EMA.
Communication is handled, with information such as deadlines, submission requirements, and other inquiries being diligently answered. Market Authorization and Maintenance is also offered, with Pharmexon’s team of experience individuals enabling smooth representation and successful maintenance, including comprehensive pharmacovigilance services, ensuring a safe and successful product life cycle.
Other services such as general local expertise, labelling and advertising compliance, and quality assurance is also offered, using the enhanced knowledge of the Pharmexon team for specific regions to help the client feel confident in their goals, knowing they have an experienced team supporting them.
Readability Testing, Bridging Reports, and Focus Test services are offered by Pharmexon and their vast array of experts. Using experts specifically experienced in each of these actions, the client can be confident that they are receiving the highest quality support.
Whether it is testing the readability of written materials, the justification of known data in a new situation, or receiving advise from focus tests, Pharmexon provides advice from experts that have many years in the industry, but also specialize in fields such as readability testing, bridging reports, or focus test. As a result, the client can be confident that the support received is from those with incredible foundational knowledge, in addition to field specific expertise.
Pharmexon offers hands-on support for many services, including the full creation of dossiers for regulatory approval. These complex documents are incredibly important, the successful submission tending to be one of the client’s highest priorities.
The team at Pharmexon, using their vast knowledge of regulatory requirements all around the world, including with agencies such as the FDA, EMA, or national regulatory bodies, can create these dossiers for their clients. The client can be confident that this creation was executed using a combination of many years’ experience in regulatory affairs, including expert knowledge, thus placing the client in a positive position when submission time arrives.
All modules can be created, with the team at Pharmexon placing an emphasis on quality, detail, and overall execution.
Pharmexon uses their wide range of knowledgeable team members and experts to offer eCTD publishing to clients, ensuring success based on regulatory experience and specific experience regarding the eCTD format, in addition to changes based on regions.
The Pharmexon team possess extensive knowledge of this format, understanding its importance in regulatory affairs and submission publishing. Clients can be confident that the eCTD publishing done by experts with comprehensive knowledge of the eCTD format, and its various variation depending on region and other factors.
Pharmexon offers comprehensive services regarding medical writing, preparing modules, and authoring. Using Pharmexon’s extensive list of experts specializing in medical writing, the client can be confident that their documentation will be executed to the highest degree by experts that possess many years in the industry, in addition to extensive experience with medical writing, module preparation, and authority. Using this experience, the client will be provided with high level documentation, specifically written for success at the agencies and regulatory bodies.
Knowing what works and what is less successful at such bodies, Pharmexon’s team of experts combine this knowledge with industry experience to greatly increase the rate of success for the client, increasing their confidence.
+420 602 378 935
Pharmexon Consulting s.r.o
Štěpánská 65, Prague 1
11000 Prague, Czechia
