Behind the Documentation
Inside Our Lab.
A walk through synthesis, analytical verification, and cold-chain operations — the work that stands behind every COA we ship.
12,000 sq ft
Combined synthesis + analytical floorspace
6
Analytical instruments (HPLC, MS, KF, LAL)
100%
Lots verified by independent third-party lab
24 hr
Maximum dispatch time post-release
HPLC + Mass Spec stations
Analytical Lab Bench
Class-100 environment
Lyophilization & Fill
Temperature-monitored
Cold Storage Vault
Synthesis to Dispatch
Every Lot Travels the Same Six Steps
No shortcuts on small lots. No exceptions on volume runs.
Raw Material Intake
Every starting material arrives with a vendor COA and is quarantined until our in-house identity check matches the vendor spec within tolerance.
Synthesis & Lyophilization
Solid-phase synthesis or fermentation depending on compound. Lyophilization to <5% residual water under controlled vacuum.
In-Process QC
HPLC for purity, mass spec for identity, Karl Fischer for water content, visual inspection for vial integrity. Every lot. No sampling shortcuts.
Third-Party Verification
Released lots are independently verified by an accredited analytical lab. We do not self-certify purity. No exceptions.
Cold Storage & FEFO
Verified lots held in temperature-monitored cold storage. Inventory rotates first-expiry-first-out — never by convenience.
Cold-Chain Dispatch
Insulated, temperature-logged shipping with cold packs sized to transit time. Loss replacement if the temperature log breaches threshold.
Analytical Methods
What We Test, How We Test It
The People in the Lab
Who Touches Every Lot
Names withheld for privacy. Credentials and roles verified at account onboarding on request.
Director of Quality
PharmD, BCPS
Method validation, lot release, regulatory documentation
Senior Analytical Chemist
PhD Chemistry
HPLC method development, mass spec identity confirmation
Process Chemist
PhD Organic Chemistry
Solid-phase synthesis, lyophilization protocols
QA Documentation Lead
PharmD
COA review, lot retain protocols, EMR-format documentation
cGMP-Aligned Facility
Documented chain of custody from raw material intake through finished, lyophilized vial.
Independent QC
Third-party lab verification on every released lot. No self-certified purity claims, ever.
Lot Retain Samples
Every released lot held in retain through full stability window for adverse-event review or audit.
Visit or Verify
Want to See More?
Verified accounts may request a virtual facility walk-through, a sample lot retain, or direct verification with our third-party analytical partner. Reach out and we'll set it up.