We are a pharmaceutical GXP consulting service with broad experience in quality and regulatory oversight of the import, manufacture and distribution of medicinal products. Our expertise includes all types of products, including solid and liquid non-sterile products as well as parenteral and Biologic and Advanced Therapeutic Medicinal Products.

We provide the following professional contract services, staff augmentation and consulting services to the healthcare industry:

Qualified Person according to Article 48 of Directive 2001/83/EC.

Responsible Person according to EU GDP guide (2013/C 343/01).

GMP and GDP Mock inspections, site audits and vendor qualification.

Pharmaceutical QMS development, implementation & embedding.

Training on key disciplines such as Root Cause Analysis, Batch review, Auditing, Data Integrity and Quality Risk Management.

Pharmaceutical MIA and WDA licence application support.

Due diligence and gap analysis for mergers, acquisitions, and carve outs.