DRUG SAFETY & PHARMACOVIGILANCE
Our team supports safety analysis right from the planning of an Investigator Brochure all the way to performing large scale review of epidemiology data.
Our services include hosted safety database, case processing, expedited reporting, aggregate report writing, signal detection and management, regulatory communication and representation as QPPV in the UK and Europe as well as similar representation in other countries.
Our global team is transforming the way in which companies have handled the medical affairs function. Integrating development, evidence generation, pricing decisions and overall medical communication is at the heart of the services we provide.
Our services include traditional medical information, writing of pricing dossier, training manuals preparation, MSL education, evidential data generation and analytics along with complete digital and legacy medical communication functions.
Soterius regulatory team prepares, submits and manages complete life-cycle of a regulatory dossier, supporting all the major steps in the preparation of a submission, liaison with the regulators, and communication and project management, with various partners for our clients.
Regulatory services include submission preparation, eCTD modules compilation, preparation of labels, annual reports preparation and management of all the other aspects of regulatory operations in the lifecycle of a product.
Soterius medical writing team has experience in handling complex innovator molecules from early development stages to consolidating clinical and other data, to producing various submission ready documents following our client's or our own SOPs.
We write clinical study protocols, clinical study reports, clinical patient safety narratives, investigator brochures, web synopses of CSRs, informed consent drafts, and many other regulatory submissions related documents.
TECHNOLOGY ENABLED SOLUTIONS
Technology enabled services across the life-cycle of a drug, device or vaccine will be the hallmark of our service to the industry and regulators. Soterius is acquiring technology rights, assets and established platforms to provide a portfolio of connected service offerings. Look out for our News and Events for announcements.