Quality Competence

A successful registration, based on transparent communication, not only permits entry to markets all over the world; it also confirms that Heraeus meets the strictest requirements for the quality of its APIs.

Preparation of Dossiers

• registration documents according to current ICH standards
• all relevant pharmacopeias (e.g. Ph. Eur., BP, USP, JP, IP, CP)
• chemical-pharmaceutical dossiers (CMC, Module 3): technical writing of the complete part - also based on customers’ raw data
• CEPs available for all APIs with a pharmacopeial monograph
• expertise in eCTD submissions and non-eCTD electronic submissions (NeeS)

Management of Registration Procedures

• registration procedures consistent with current guidelines and predetermined timeframes
• assistance in providing additional technical information
• competent personal contact at all stages of the registration process

Life Cycle Management

• regulatory support for existing products
• continuous improvement of documentation
• established change control system
• professional change management with customers and authorities in line with the current Variation Regulations

Heraeus constantly secures the outstanding quality of its active pharmaceutical ingredients and strictly follows international regulations in order to improve the quality, safety and environmental standards constantly:

• Release of hAPIs
• Supervision of GMP compliance & quality
• Document management
• Internal and external auditing
• Training of staff and management
• QA agreements

Heraeus is fully established in the performance of a wide range of the latest analytical techniques. All work on in-process control, raw materials, intermediates, and release testing of APIs is conducted according to GMP and ICH guidelines.

Our Services

• Release of raw materials
• Quality control of intermediates and hAPIs
• Stability testing of hAPIs and final dosage products
• In-process control
• Full characterization of reference standards
• Development and validation of analytical methods
• Identification of unknown impurities / degradation products