Validation & Qualification, Compliance Support
Validation & Qualification
Q/V services – tailor-made and compliant
In regulated industries, compliance with legal requirements is essential for safety and quality.
- Facilities
- Package units
- Cleanrooms
- Cold rooms and storage
- HVAC
- Monitoring systems
- Equipment
- Media
- Raw materials
- Computerized systems (CSV)
- Cleaning procedures
- Manufacturing processes
- Sterilization processes
- Analytical methods
- Packaging
- Transportation
- Master plans (QMP / VMP)
- Concept development
- Risk analysis
- Bracketing concepts
- URS
- FAT/SAT
- DQ/IQ/OQ/PQ
- SOPs
- Periodic reviews
- Audit trail reviews
- Trainings
We offer tailored qualification and validation services specifically designed to meet the requirements of companies in the pharmaceutical, medical device, chemical, biotech, and other branches. Regardless of size or structure of your company, we develop solutions that are precisely aligned with your individual needs and regulatory requirements.
Selected regulations and best practice:
EudraLex Vol. 4 Annex 1, Annex 11, Annex 15, FDA 21 CFR, GAMP 5, and more.
Compliance Support
Individually tailored compliance services, focused on your long-term success
Regulatory requirements are complex and challenging – but with the right partner at your side, compliance becomes a competitive advantage.
- Pharmaceutical industry
- Biotechnology and biopharma
- Medical devices
- (Fine) Chemicals
- Health care
- Food industry
- Cosmetics
- Suppliers
- Testing laboratories
- Regulatory changes
- Quality management
- Risk management
- Document management
- CAPA / change management
- Deviation management
- Data management and data integrity
- GAP- and risk analysis
- Hygiene concepts
- Auditing
- Supplier qualification
- Trainings
- Quality seals / labels / certification marks
- Nutri-score / extensions
- Nutritional labelling
We support your company in implementing and evaluating compliance with legal and normative requirements.
Selected regulations and best practice:
ISO 13485, ISO 9001, EU regulations, GxP guidelines, EudraLex Vol. 4, FDA 21 CFR, MDR, ICH, and more.
