Plan the regulatory checkpoints for your clinical study to improve the quality of regulatory documentation and secure timely approval
Wherever you plan your clinical studies, we provide you with a full team of expert regulatory consultants, with knowledge at the forefront of innovation and compliance.
We can accompany you from the definition of your Clinical Trial filing strategy and planning, through identification and controls of regulatory requirements, up to submission and correspondence with evaluating bodies, including the critical step of response to evaluation queries from both health authorities and EC/IRBs.
Check our Clinical Operations, Biometry, and Clinical Safety capabilities to give life to your clinical studies.
Partner with highly qualified regulatory consultants and savvy subject matter experts, mastering clinical research and your technology’s specificities
Whether you are developing a medicinal product (small molecule, biologics, ATMP, live biotherapeutics, GMO), a medical device (hardware and/or software), or a combination of these, it is in VCLS’ DNA to combine regulatory and science to make challenges into opportunity.
Our regulatory specialists team up with in-house subject matter experts (CMC, nonclinical, clinical, data privacy, market access, patient engagement, and more) to support your program with the review and development of core study and product documents (study protocol, quality/technical documentation, investigator’s brochure, consent documents), and application package components.
Ensure compliance with applicable standards and reduce the risk of evaluation queries with VCLS’ Legal Representation and Compliance Partner services
Wherever you conduct your clinical studies, the local framework may require you to be represented locally.
At VCLS, we offer legal representation services alongside with regulatory support for clinical studies in the EU, the United Kingdom, and importantly providing a US Agent to meet the regulations for ex-US sponsor’s conducting trials in the US under a US IND. Furthermore, VCLS relies on a trusted network of partners to coordinate local representation.
At the forefront of every groundbreaking regulatory change, we are proud to align with non-EU sponsors acting as both a Legal Representative and a Compliance Partner, providing a finely calibrated set of services to ensure compliance with every key aspect of the EU/EEA framework during the critical steps of preparation and start-up of clinical trials. Similarly, for EU-sponsors we offer a knowledgeable regulatory team to serve not only as US Agent, but to provide both regulatory strategy and submission logistics, recognizing, unlike in EU for CTAs, the FDA’s electronic/eCTD requirements even at the pre-IND stage.
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