At Pharmexon Consulting, comprehensive risk minimization services ensuring the safety and efficacy of medicinal products throughout their lifecycle is offered. Extensive expertise in pharmacovigilance and regulatory requirements allow Pharmexon to create robust risk management strategies tailored to each product’s unique profile and market conditions.
Routine risk minimization activities are the backbone of Pharmexon’s approach, encompassing measures applied universally to all medicinal products. These include:
Pharmexon rigorously craft these documents, providing healthcare professionals and patients with vital information about the medicinal product. The SmPC and PL contain routine risk communication messages, highlighting potential adverse effects and specific clinical measures to manage risks, such as dose adjustments, monitoring protocols, and contraindications.
Pharmexon ensures that product labels and packaging are clear, accurate, and complying with regulatory standards, reducing the risk of medication errors and misuse.
Pharmexon helps determine the appropriate legal status for each product, whether it requires a prescription, restricted medical prescription, or special medical prescription. This ensures that products are only available under conditions that minimize the risk of misuse and adverse reactions.
Beyond routine measures, certain products necessitate additional risk minimization activities to address specific safety concerns. Pharmexon’s team conducts thorough risk assessments and develops targeted strategies, which may include:
Pharmexon creates detailed educational materials for healthcare professionals and patients to ensure they are fully informed about the product’s risks and the necessary precautions.
Pharmexon offers training programs to ensure that healthcare providers understand the specific risk minimization measures associated with a product.
For high-risk products, Pharmexon designs and implements controlled distribution systems restricting access to authorized personnel and settings.
Pharmexon provides extensive biowaiver support, bridging the gap between the client and the regulatory body. The team of experts at Pharmexon can help the client classify their product, advising based on previous experiences at agencies, knowing what strategies are successful. Pre-submission study support in addition to helping the client prepare their biowaiver submission are also offered utilizing wide regulatory expertise that does not stop with a single geographic region. Pharmexon can provide support for full Biowaivers, strength-based biowaivers and extrapolation of CMC data to support development ideas.
Offering a wide range of support for clients dealing with agency deficiency responses, Pharmexon understands the importance of dealing with such responses in a timely and comprehensive manner. Pharmexon’s wide range of experts can assist with everything from Complete Response Letters (CRL’s) to deficiency letters and questions during approval review. The team at Pharmexon can offer gap analysis identifying the improvements needing to be made, in addition to allocating resources and producing a timeline, using a hands-on approach ensuring that the client is left in a much stronger position given the setback.
Pharmexon can even support as a liaison to the regulatory body, being with the client the entire journey, also offering training, reducing the likelihood of further setbacks. Efficient and knowledgeable, Pharmexon can help the client come back stronger from agency deficiency responses.
Pharmexon can assist in the pre-development, strategy, development, studies, and post-study regulatory submission ensuring that the client is equipped with the knowledge of potential feasibility, in addition to the best options given their specific situation. Using experts with comprehensive knowledge of not only the regulatory body but also the IVIVC process in general, the client will be at an advantage come submission time given the extensive support received over the entire process. Utilizing Pharmexon strengthens the client’s chances of a success IVIVC submission boding well for other regulatory actions.
Understanding the heavy financial burden trials have on companies, Pharmexon looks to ease such a burden the utilization of a vast array of experts specially equipped to support in every aspect of clinical and preclinical development strategies. Whether it is Phase 1 through Phase 4, Pharmexon can advise the client on study design, ensuring that the strategy design accurately represents the drug’s goal and hereby increases the chances of successful future registrations.
Experts with specializations in fields such as PK, pre-clinical or clinical trials can be consulted, allowing the experts to use their many years of experience to help the client pick the best direction and design for the clinical and preclinical trials, looking to certifying the heavy financial burdens as successful investments.
Deciding on the formulation of a drug is an incredibly important first step in its development. Pharmexon works with the client to set them up for success at the very beginning of the developmental process, something the client can carry into the other stages. Utilizing a vast array of knowledgeable experts, many of whom specialize in formulation, the client can be advised by those who know best and have a passion for the industry.
The advice can cover everything from bioavailability and bio equivalence to manufacturability and importantly regulatory compliance. For the safety of patients and the success of the proposed medicinal product, Pharmexon works to advise the client with a hands-on approach, ensuring the client can easily have questions answered during the early days of the development process.
From site selection to regulatory amendments, Pharmexon can assist the client in the process of site transfers. Expertise from Pharmexon’s team can advise the client on best practices for choosing new manufacturing sites, given the unique factors their situation possesses. Amending regulatory filings can also be made smoother through Pharmexon’s consultation, as the team is already knowledgeable about such variations, knowing exactly what is needed, increasing efficiency and overall success of the transfer and regulatory compliance.
Pharmexon offers an extensive list of experts and other knowledgeable individuals who can advise the client on the entire process, from deciding what variations to make, to the practical act of submitting these variations. Using comprehensive experience in the industry, Pharmexon can consult with the client, set them up for success based on their specific situation.
The wide range of variations and their severity allows Pharmexon to shine, matching experts with regulatory body experience and a passion for the industry with clients who need assistance to maximize their potential success. Pharmexon does not just focus its resources on one geographic region, ensuring that the clients have the freedom to choose, knowing they will be supported.
Expert statistical consulting is offered by Pharmexon and its extensive team, navigating the complex nature of CMC and Biostatistics for the client, allowing them to focus on other business activities while still being set up for success. Guidance on study design all the way to submission, Pharmexon offers a hands-on approach to consulting, allowing the client to let experts in these fields optimize the client’s regulatory compliance.
+420 602 378 935
Pharmexon Consulting s.r.o
Štěpánská 65, Prague 1
11000 Prague, Czechia
