Home
We Are Experts in Drug Safety and Pharmacovigilance Services
We are ready to help you.
Safety Sphere, LLC is a women-owned business with over 20 years of pharmacovigilance experience. We are a full-service consulting firm.
Your team can count on us to help you build your drug safety departments and guide you through all aspects of the pharmacovigilance process.
Our focus is on small to mid-size pharmaceutical companies, emerging biotechs, and contract research organizations (CRO).
Our Top Priority: Ensuring Regulatory Compliance for Your Team
In the constantly changing regulatory climate, Safety Sphere will work with your organization to ensure compliance with current FDA and international regulations.
We will guide you to build the framework that aligns with your product lifecycle.
Together, we will support your company’s expedited and periodic submission compliance by providing…
✔ FDA and International Regulatory Audit Preparedness
✔ Timely SAE Case Processing
✔ Drug Safety Narrative Writing
✔ Signal Detection and Evaluation
✔ Consistent MedDRA/WHO Drug Medical Coding
✔ Drug Safety Team Training
✔ Drug Safety Team Development