Quality Competence

Extensive analytical capabilities, qualitiy assurance and the full reliability of a partner are extremely important to pharmaceutical clients worldwide. Heraeus constantly secures the quality of active pharmaceutical ingredients, strictly follows international regulations and prepares and maintains all documentation for initial and existing registrations worldwide.

Regulatory Affairs

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 hAPIs.

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 hAPIs 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

Quality Assurance

Heraeus constantly secures the outstanding quality of its highly active pharmaceutical ingredients and ensures a continuous improvement of quality, safety and environmental standards through its comprehensive services:

  • Release of hAPIs
  • Supervision of GMP compliance & quality
  • GMP compliant document management
  • Auditing of internal departments as well as external suppliers
  • Training of staff and management
  • QA agreements

Quality Control

Heraeus is equipped with the most state-of-the-art analytical techniques: process controls, analysis of raw materials, intermediates, and release testing of hAPIs are conducted in compliance with cGMP and ICH guidelines.

Our Services

  • Release of raw materials
  • Quality control of intermediates, in-process controls and hAPIs
  • Stability testing of hAPIs and raw materials (if required)
  • Full characterization and qualification of reference standards
  • Development and validation of analytical methods
  • Identification of unknown impurities / degradation products