Consulting for all Stages of Development
At Aurous Safety we pride ourselves on being a boutique consulting firm specializing in pharmacovigilance. Our mission is to empower biotech companies by providing tailored safety solutions.
What Sets Aurous Safety Apart:
Our team is comprised of seasoned professionals with deep knowledge of pharmacovigilance. We’re not a one-size-fits-all consultancy; we’re dedicated to this critical field.
Aurous Safety partners with biotech innovators to navigate safety challenges proactively. We’re not just consultants; we’re your strategic allies. We focus on quality over quantity by taking on a select number of clients to ensure personalized attention and impactful results. With a diverse client portfolio from “first in human” ventures to established biotech giants, we’ve collaborated with a wide spectrum of clients. Our experience spans the industry.
Some Services We Offer
Safety Operations
System and Information Management
Risk Management
Medical Writing
Quality Management
Regulatory Filings
Frequently Asked Questions
When is the best time to engage PV Consultants?
One of the best parts about our services is we can help with advice or strategy. Engagement do not need to be for full-service department set-up. We can set up a call to determine if there is a need for consulting support of merely advice from time to time. We have clients who have engaged us well before they submitted their IND and those who needed an evaluation prior to a reorganization.
Do I need a PV/Safey team or specialist in place before engaging a PV consulting service like Aurous?
No. It is not uncommon to engage a well versed and experienced Pharmacovigilance Consultant to help anyone from a founder or C-level individual to help assess and enact the overall first steps in building a PV program as well as safeguard against early missteps that companies without a PV presence can make early on without knowing it.
What if we need to hire a CRO? Do you offer services to help with this?
Yes! We can assist with review of the outgoing request for proposal (RFP) to ensure the request covers the need. Once bids are received, we will work with your team to make sure the particular requirements of your study are met and negotiate competitive pricing with vendors.
Do you specialize in a therapeutic area?
Most of our recent clients have been working to develop novel products in oncology and autoimmune indications. Our consultants have unique experience working on early CAR T development and enjoy sharing their ‘lessons learned’ from those early days. Other areas of focus include neurology, cardiovascular, and pain management.
Contact Us
email: Inquiry@AurousSafety.com
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