Analytical Services and Quality Management

Instruments
Quality Management
Structure Elucidation
Syntheses
Projects


GXP & More

Quality Control, Release, GMP, GLP and Storage

Because of its unique network, Analytical Services is able to offer the whole service of quality control: from raw material release to batch release.

Quality is not a duty,
it´s a commitment.

Services:

Technical Writing
Writing & updating your IMPDs, SOPs, protocols, reports, INDs (CMC)

Release of Drug Products and Drug Substances
Release of NCEs and NBEs by a Qualified Person

ICH Stability Studies
Storage of Drug Products and Drug Substances

Syntheses and Storage of Reference Standards
Pharmacopeial standards, non-pharmacopeial standards

Method Development & Validation
Planning, lab work, reporting

Relevant Links:

- CHMP Guideline for IMPDs

- ICH Guidelines

- Common Technical Document (CTD)

- EMEA Guidelines

- Note for guidance: specification limits for residues of metal catalysts

- Note for guidance on development pharmaceutics

- BfArM Homepage

- Swissmedic Homepage

- About the Qualified Person