Supera Fulfillment, LLC

Supera Fulfillment is a healthcare-focused contract manufacturer and regulated 3PL built around medical device quality standards rather than adapted from general logistics. Founded in 2020 by Sitara Waidyaratne, a clinical laboratory director with 25 years of experience, and co-founded with Michael Brown, a scientist and laboratory supply veteran with more than 25 years in the industry, the company operates as an FDA-registered device establishment (Reg. No. 3018077536) with ISO 13485:2016 certification. The Houston facility features an ISO Class 7 cleanroom where specimen collection kits, diagnostic test kits, clinical trial kits, and at-home testing products are assembled with documented lot traceability and QC release on every lot.

Supera's core differentiator is that it was designed by people who came from the laboratory side of healthcare. The company runs dozens of active kit programs for CLIA and CAP accredited laboratories across diagnostics, genomics, and at-home health. Services span the full lifecycle of a kit program: component sourcing from established diagnostic manufacturers; precision aliquoting on Hamilton STAR automated liquid handling systems; cleanroom assembly with QC inspection to the AQL and sampling plan each program's SOP specifies; cold chain storage and temperature-controlled shipping; direct-to-patient fulfillment; compliant specimen return packaging under UN3373 Category B; and international shipping with customs documentation. The company also handles medical device and equipment distribution across all 50 states.

Supera scales from pilot builds of a few hundred kits through ongoing commercial production, and evaluates fit based on the program rather than a minimum order quantity. Client onboarding covers product intake, SOP development, system setup, and receiving of initial inventory. Supera positions itself as a compliant extension of its clients' regulated supply chains rather than an external vendor.