Today the economic success is not only based on the product quality but also on the quality of processes. Many rules define product specification and standards in manufacturing and distribution. They have a deep effect in the daily routine of pharmaceutical industry and medical device enterprises.
The regulation for pharmaceutical plants (AMBO, Arzneimittelbetriebsordnung, German) regulates the implementation of Pharmaceutical Quality Assurance in manufacturing (GMP, Good Manufacturing Practice) and distribution (GDP, Good Distribution Practice) of medicinal products. It details the establishment and control of pharmaceutical processes like document management, hygiene program, supply chain and logistics, order processing, complaint management, change control management, contract processing, risk management, etc.
To install adequate processes in a specified company it needs an individual status quo analysis (see audits) and a target analysis arranged by an experienced certified quality manager and auditor (see qualification). Whether you strive for QMS regarding ISO 9001:2008 or single processes, or whether you need Standard Operating Procedures (SOPs) or only a process-overview – PharmaExpert will find a competent answer mainly suitable fort daily use. 
The clinical trials or the handling of investigational medicine requires an adequate quality system alone due to the comprehensive documentation requirements concerning GCP, Good Clinical Practice. Substantiated experience in organisation and procedure of clinical trials and clinical development programs enables the efficient implementation of requests (see clinical trials)

Overview about QM activities:

• Quality management system –  consultancy, buildup, implementation
• Compilation of QM-documents
• Quality Manual – ISO 9001 conform creation, implementation and maintenance
• Process description – workflow, process schema
• SOP- writing, review and revision, document overview
• Pharmaceutical Qualitiy Assurance concerning AMBO (regulation for pharmaceutical plants)-consultancy, creation of AMBO conform documents
• Risk management, Change Control Management
• Contract procedure
• Quality control - organisation and advice
• Quality Assurance Training, workshops
• Qualified Persons services as certified quality manager (GCP, GMP) or competent person for Pharmaceutical Quality Assurance (GDP)