Quality and compliance
Company and technical model
NexaGens B.V. is a Netherlands-based B2B developer and supplier of value-added ingredients, established in 2026. NexaGens develops, specifies, commercialises and supplies products; it is not the physical manufacturer of every product.
NexaGens is supported by Netherlands-based R&D and quality-control resources within the Nova Techs group, together with qualified external technical partners. Technical and formulation capability includes PhD-level expertise without implying that every specialist is directly employed by NexaGens.
Development and manufacturing responsibilities
NexaGens manages or approves target product profiles, technology and delivery-platform selection, raw-material and critical-excipient selection, product and functional specifications, test requirements, acceptance criteria, technical-document coordination, change control and ongoing product improvement.
Detailed formulation work, pilot and commercial manufacture, process scale-up, analytical testing and specialist characterisation are performed jointly with, or executed by, qualified manufacturing, laboratory and technical partners under product-specific requirements and quality agreements. The applicable manufacturer and country of origin are confirmed for the individual product and batch.
Quality oversight
NexaGens operates a documented, risk-based quality framework. Manufacturing and batch testing are normally performed by the applicable manufacturer or a qualified laboratory; NexaGens reviews the resulting evidence against the approved product requirements.
- Supplier, manufacturer and service-provider qualification
- Specification, CoA and supporting-document review
- Analytical and stability evidence review
- Batch traceability, document control and change control
- Deviation, nonconformity and corrective-action oversight
- Complaint handling, recall coordination and periodic review
Commercial batch release
The manufacturer releases a batch under its own quality system and provides the applicable batch documentation. NexaGens makes the final commercial batch-release decision after reviewing the relevant manufacturer and laboratory documentation against the approved product specification for products supplied under the NexaGens name.
Product-specific characterisation
Testing and acceptance criteria are selected according to the product, technology and intended technical function. Depending on the product, evidence may address active loading, physical characteristics, dispersibility, stability, sensory performance, dissolution or release behaviour and other relevant parameters. A platform name alone does not establish structure or finished-product performance.
Technical documentation
Technical documentation is available on request, subject to the product's qualification status, applicable manufacturer and relevant batch. NexaGens confirms the current document set for each enquiry.
Depending on the product, this may include a batch-specific CoA, TDS, SDS, product specification, stability or shelf-life information, quality statements, composition and origin information, microbiological or contaminant information, storage and handling information, release or dissolution data, analytical-method information, partner certificates and regulatory statements. Confidential or proprietary information may require an NDA.
EU regulatory support
NexaGens provides product-specific technical documentation and ingredient-level information to support customers' EU regulatory assessments. The finished-product manufacturer remains responsible for confirming the compliance of its final formulation, dosage, claims, labelling and intended market.
Availability and supply
Product maturity, sample availability, commercial availability, documentation, packaging, minimum order quantity and lead time are confirmed individually according to the product, manufacturer, batch status and customer requirement.
Request quality documentation
Tell us which ingredient you are evaluating, the intended application and market, and the documents your formulation, quality or regulatory team requires. NexaGens will confirm the product's current qualification status and available document set through the controlled technical-document request process.