Clinical research · Regulatory · Consulting
Senior people on
your study.
The X factor in your development programme.
Bionergyx is a global healthcare and life sciences organization. We plan, run and document clinical development programmes for pharmaceutical, biotech and medical device companies internationally, with the same people from first protocol to final report.
Our procedures are written against
- ICH-GCP (E6)
- Declaration of Helsinki
- 21 CFR Part 312
- EU CTR 536/2014
- GDPR
What we do
Four things, done properly.
Most programmes stall in the gaps between clinical, regulatory and commercial work. We cover all four so nothing falls into a gap, and so you are not managing three vendors who each hold a piece of the story.
Clinical Research
Protocol and development planning, site feasibility and activation, monitoring, regulatory submissions, medical affairs and pharmacovigilance.
Read moreHealthcare Consulting
Second opinions on development plans, quality systems, SOP frameworks and the operating model behind a growing clinical function.
Read moreStrategy Consulting
Portfolio and market entry questions, partner search, and the commercial case that sits underneath a development decision.
Read moreInnovation & Technology
Structured quality control for clinical and regulatory documents: version checks, discrepancy flagging and evidence that is traceable to source.
Read more
Who we are
A global organization, built by people who have run the work.
Bionergyx was founded in 2025 as a global healthcare and life sciences organization and is led by Deepti Goel, who spent more than twenty years in clinical operations, GCP training and quality systems before starting the company. It is built on the work of the late Dr. Martin Bauer, a physician and pharmaceutical executive whose approach to clinical development still shapes how we run studies.
Why Bionergyx
How it is to work with us.
You work with the seniors
There is no account layer between you and the people running your study. Whoever answers your first email stays with the file.
One global team
International work is handled inside our own team, across sites and health authorities in different regions, instead of being passed on and relayed back to you.
Written down, not improvised
Document control, training records, monitoring, CAPA and risk all follow written procedures. Every finding traces back to its source.
Close enough to answer
One named contact who knows the file, and a reply within one business day.
- 01
First email
Write a few lines about where your programme stands and what is holding it up. We reply within one business day, at no cost.
- 02
Written scope
We put the work, the assumptions and the price in writing, including what we would not recommend doing.
- 03
Named team
You get the people, not a pool. Roles, availability and escalation path are agreed before we start.
Tooling
We automate the checking, not the thinking.
Consistency checks across document versions, discrepancy flagging in tables and figures, and structured QC of regulatory documents. The tooling prepares and flags. A qualified person reads, decides and signs.
Tell us what is stuck.
Send a short description of your programme to info@bionergyx.com and we will tell you plainly whether we are the right people for it, and what we would do first.