ISO 9001 for LifeScience Manufacturers

PharmOut provides Templates and Consulting Services to Small to Medium Sized Companies.

As well as ISO 9001 templates, we can help you with:

ISO 13485 Quality Systems
QSR / 21 CFR 820 Quality Systems

Regulatory knowledge, practically applied

Ours is an affordable and practical approach to implementing ISO 9001 systems. We provide templates and consulting services to meet the needs of small/medium size pharmaceutical, biotech or medical device manufacturing companies, to ensure their registration to ISO 9001. Our systems also ensure compliance to the MCC's and if necessary the FDA's requirements.

Companies typically complete registration to ISO 9001 within 6 to 12 months. PharmOut will help clients achieve registration on schedule. By installing quality systems that will generate hard-dollar savings / improvements and operate with minimal maintenance costs and you will reap the rewards sooner.

Applicability of ISO to Pharma / Biotech

The ISO 9001:2000 Standard provides an excellent framework to develop a Quality System fully compliant with the PIC/S requirements.

Whilst a Quality System is not a specific requirement of the USA's Food and Drug Administration it is recommended as it will assist in compliance to the Code of Federal Regulations; in particular the 21 CFR 210 and 211.