Pharmaceutical and API Industry

Pharmaceutical manufacturing has one fundamental constraint: contamination control is not a feature, it is the product. We design and build Grade A to Grade D cleanrooms for active ingredient manufacturing, solid and liquid dosage form production, and aseptic filling operations — with deep experience in GMP Annex 1 (2022 revision), Directive 2001/83/EC, EMA guidelines and FDA 21 CFR Parts 210 and 211. ICH Q7 for active substances. ICH Q9 for risk management. GMP Annex 15 for qualification and validation.

DQ/IQ/OQ/PQ as a standard deliverable. Our engineering team works with the Quality Assurance function and the Qualified Person from the design phase. For the Spanish-speaking market: AEMPS (Spain), COFEPRIS (Mexico), ANMAT (Argentina) and INVIMA (Colombia) — all with procedures that recognise EMA and FDA as authorisation references. A well-built but poorly documented facility is not a qualified facility.