OUR EXPERTISE

Soterius has expertise in Global Drug Safety, Pharmacovigilance, Medical Affairs, Regulatory and Medical Writing.  Our team has worked with some of the top global corporations across the world, handing diverse regulations and requirements. 

We are passionate about finding solutions and providing excellent quality services to our clients.

Our quality systems are compliant, we are 24x7 available and always inspection ready.

Soterius' clients are global.   We service Innovator Pharmaceutical companies, Generic Drug Manufacturers, Regulatory Authorities and have support arrangements through global CROs and technology solutions providers to augment our own resources.

 

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.

MEDICAL AFFAIRS

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.

REGULATORY OPERATIONS

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.

MEDICAL WRITING

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.

Phone: (212) 203 0450

3150 Brunswick Pike, Suite #220, Lawrenceville, NJ 08648