Consulting

Concept Heidelberg also manages the comprehensive advisory services in the field of GMP and Regulatory Compliance for the Pharmaceutical Consulting Alliance (PCA).

PCA is an association of leading GMP experts from various areas of the pharmaceutical and active pharmaceutical ingredients (API) industry. All of them are recognised specialists with long-standing practical experience – e.g. as Qualified Persons, QA/QC Managers, Production and Development Managers. Clients therefore benefit from consultants who can discuss their situation with further experts. Moreover, PCA’s international presence – the consultants come from England, Switzerland and Germany and have established networks of contacts – enables you to quickly contact various European supervisory authorities. These contacts are often the key to the solution of (GMP) problems.

Benefit from a consultants team supporting you on all GMP and Regulatory Compliance matters

• from GMP audits (current state analysis)
• to overarching advice and inspection preparation.

The Pharmaceutical Consulting Alliance offers counsel for all relevant departments and fields of expertise:

• Aseptic / sterile manufacture
• Biotechnological production
• Solids production
• Production of APIs
• Production of excipients
• Quality Assurance
• Quality Control
• IT/EDP
• Engineering (water systems, HVAC systems)
• Pharmaceutical development

PCA services are based on the following standards:

• FDA
• EU/EMA
• WHO
• PIC/S
• Pharmacopoeias (EP/USP)

To find out more about the Pharmaceutical Consulting Alliance, please visit
www.pca-gmp.com.