Expertise

Competence you can verify —
not just claims you have to believe.

Frameworks, industries and project environments. If you work in a regulated industry, you will recognise the territory.

01 Frameworks & Standards

The regulatory ground we work on.

Our work is built on the current GxP framework landscape — Swiss, European and US — and on the risk-based methods the industry has converged on.

EU GMP Guide EU GMP Annex 1 (2022) EU GMP Annex 11 EU GMP Annex 15 FDA 21 CFR Part 210/211 FDA 21 CFR Part 11 ICH Q7 – Q10 GAMP 5 (2nd Edition) ASTM E2500 ISO 13485 ISO 14644 Swissmedic requirements

02 Industries

Regulated production, in all its forms.

Pharmaceutical

API & drug product manufacturing, aseptic processing, packaging lines, quality control laboratories.

Biotechnology

First GMP facilities, scale-up, tech transfer — where speed and compliance must move together.

MedTech

ISO 13485 / MDR quality systems, cleanroom qualification, sterilisation and process validation.

Food & Nutrition

Hygienic design, process validation and quality systems for food production.

Cosmetics & Care

GMP-compliant cosmetics production and quality control (ISO 22716 context).

03 Selected Project Experience

Environments our experts know from the inside.

Selected project experience of our experts includes assignments involving leading international pharmaceutical and biotechnology companies such as Bayer, Lonza, Aenova / Haupt Pharma, Recipharm and Bachem.

Experience gained by our experts in the course of their professional project work. This does not imply current client relationships or official endorsements. Confidentiality obligations towards past and present clients apply; specific project details and reference contacts are available on request where contractually permitted.

Stainless-steel process tanks in a modern hygienic production plant Process Plant

/ Typical mandate

New GMP facility

CQV strategy, master plan, qualification of cleanrooms, utilities and process equipment up to PPQ readiness.

/ Typical mandate

Inspection remediation

Structured response to authority findings: gap assessment, CAPA plan, requalification and documentation repair.

/ Typical mandate

Digital validation

CSV of manufacturing and quality systems per GAMP 5 — including data integrity and Part 11 assessments.

Next step

Tell us about your project environment.

We will tell you honestly whether and how we can help — usually within 48 hours.

Discuss a Project