Pro-Eko Srl

Pro-Eko Srl is an Italian B2B manufacturer of chemical reagents and in vitro diagnostic (IVD) devices, founded in 1983 and headquartered in Petacciato, Molise, Italy.

We operate exclusively as a contract manufacturer and production outsourcing partner for companies in the chemical, pharmaceutical, and diagnostics industries. We do not sell to end consumers or retail channels.

WHAT WE PRODUCE:

- Chemical reagents — standard formulations and fully custom development on client specification

- IVD devices — Class A under EU Regulation 2017/746 (IVDR), produced under our own quality system

- Production outsourcing for IVD Class B and Class C projects — supporting manufacturers who retain legal and regulatory responsibility for their devices

- Contract filling, packaging and labelling — according to client technical specifications and B2B workflows

OUR QUALITY SYSTEM:

ISO 9001 certified since 2000. Every production batch is fully traceable: raw material controls, critical process parameter registration, finished product verification, and documented non-conformity management.

REGULATORY DOCUMENTATION:

We provide full technical and regulatory support for the products we manufacture: Safety Data Sheets (SDS), CLP classification, IVDR technical files, PCN/UFI notification, and related documentation.

Founded: 1983 | ISO 9001 certified: since 2000 | Market: B2B only

OPERATIONAL CONTINUITY
Active since 1983, without interruption. In a sector where supplier qualification takes time and resources, continuity is not a biographical detail — it is an operational guarantee. Our clients do not restart qualification processes every time they place an order.

QUALITY AS PROCESS, NOT DECLARATION
ISO 9001 certification is a baseline, not an achievement to display. Full batch traceability, documented process controls, and structured non-conformity management are the concrete forms quality takes in our daily operations.

TECHNICAL HONESTY
We do not commit to what we cannot produce. Every project begins with a real specification review: compatibility, stability, scalability. If a technical or regulatory constraint makes a project unfeasible under the required conditions, we say so at the start.

DEDICATED B2B ORIENTATION
We work with companies, laboratories, and qualified supply chains. We understand the needs of clients managing recurring orders, requiring batch documentation, and meeting regulatory deadlines. Our structure is built for this.

INTEGRATED CONTRACT MANUFACTURING
For our clients, outsourcing production to Pro-Eko means working with a single, stable industrial partner — from specification to finished product, through formulation development, scale-up, quality control, and packaging. No handoffs between suppliers.

REGULATORY COMPETENCE INCLUDED
SDS, CLP, IVDR, PCN-UFI: regulatory documentation is treated as a component of the product, not an optional service. When clients need it, regulatory support is part of what we deliver.