Biologics Regulatory and Quality Services

Helping you set a course for success and get to market

  biologics vial


Whether you’re a small life science company or an established entity, you can turn to Safis Solutions for insights that expedite product approvals and improve manufacturing processes. We demonstrate full regulatory and life-cycle process knowledge at strategic and tactical levels to meet your objectives.


You work fervently to ensure the quality of your life science product. We work with this same passion to ensure that your products get to market as quickly as possible.



 regulatory compliance consulting


Regulatory Compliance

Regulatory submission preparation

Authorized representative for foreign companies

Assistance with ongoing compliance requirements

And more


quality compliance services


Quality Compliance

Quality assurance management

Auditing/review of third-party vendors

Remediation services

And more


 computer systems validation


Computer Systems

Requirements gathering and development

Data migration

Assistance with vendor selection and auditing

And more