Any sufficiently advanced strategy is indistinguishable from magic.

Interpretation of the legislation and liaising with the authorities can look straightforward.  But, it is not how it looks, on the contrary.

We speak the language of regulators and can support you.

Clinical trial applications, new or updated are to be communicated with all stakeholders via certain platforms.  We are good at this as our team has experienced clinical regulatory operation executives.

Relevant requirements from regulations or standards should be met to achieve product high-standard quality, safety, and efficacy. Commitment to continual compliance is the key and we are here to help you.

Collection of Regulatory intelligence can be challenging. EU is the school example of this kind of challenge. 

Even being aligned at the union level, every member state (MS) keeps its right to cherish local specifics and insist on their fulfillment. 

We are proud to state that we had an opportunity to interact with ALL  of them, directly or indirectly.

Process efficiency, quality management & people-centricity are three core principles of Operational Excellence (OpEx). And we follow them all.

We maximize the utilization and minimize the waste of time and resources, being committed to continual improvement in every aspect of regulatory operations.

Contribution to innovation is the core of our mission. 

We empower our customers to initiate correspondence with the authorities as early as possible and to get input for the proof-of-principle or proof-of-concept of their product.

Proactivity is the key, especially in the preclinical stage, contributing to study design & overall clinical trial success.

We led or participated in the creation of many regulatory strategies aligned with the stage of product development and available data.

What we learned is that the best strategies are the ones with strong agility.  

Circumstances can be changed but the targets stay the same, to succeed, the agile guide is the key.

Patient safety is vital. If you cannot help, do not harm. Simple as that.

Our team serves to improve the processes and operations within Pharmaco & Materiovigilance, as well as to ensure allocations of the safety experts and their timely assessments & inputs serving the patients' safety & well-being.

Members of our team are experienced medical writers. 

We can support you in compiling a complete Common Technical Document (CTD) for medicinal products or a Technical Document for medical, in vitro, or digital devices.

We need to assess your available data and set the timelines, and your dossier or tech file will be timely delivered.