||We are an internationally acting and continuously expanding service company with a subsidiary in Laufenburg, Switzerland and our main office in Mannheim, Germany. Almost 50 experienced associates from different technology fields are ready with their special know-how to support our clients in all matters of GMP. Most of our employees have been active in the field of GMP and comparable quality systems for many years. In addition to this, we emphasize the maintenance of our high level of knowledge by means of internal and external training, further education and active memberships in various associations.
Our main activities are professional executions of validation and qualification projects, including high-level consulting in the field of GMP. This also includes continuous mentoring in all matters concerning the daily GMP business.
To attend to the individual demands of our customers in a professional and precise way, we are organised into four separate and topic-based business units:
API / CHEMISTRY
Individual support of chemical, food, feed and cosmetic industry producing active pharmaceutical ingredients or excipients.
PHARMACEUTICS / BIOTECHNOLOGY
Specific support of pharmaceutical and biotechnological industry with know-how in solid, semi-solid, liquid and sterile dosage forms as well as in biotechnological products.
Intersectional unit which supports validation of computerised systems or client-specific software packages such as PCS, Excel Spreadsheets, ERP (SAP), LIMS and single-position software systems.
Intersectional and multi-focused unit which supports onsite, either permanently or temporarily, with personnel capacities in quality assurance questions such as qualification of equipment, validation of processes or the development and maintenance of SOPs and master plans.
Our modular service concept is highly practice oriented and ranges from initial information through the development of suitable concepts to the accompainment of audits. Our clients are able to choose not only an integral project attendance, but also individual elements such as:
- GAP analysis
- Optimisation of GMP systems
- CIP / SIP, hygienic design, user requirement specification
- Process analysis (ICH Q9, FMEA, HACCP�)
- Preparation of master plans (Validation Master Plan, Hygienic Master Plan, Site Master File)
- Qualification of equipment (DQ, IQ, OQ, PQ)
- Process validation (production, cleaning and analysis methods)
- Validation of computerised systems (GAMP, Annex, Part 11)
- Development and maintenance of SOPs
- Preparation and accompaniment in audits (client, authorities, contractor)
- Individual consulting in GMP
We deliver a refined concept to meet the GMP requirements of our clients and which proves that well-considered solutions are not necessarily expensive.