Interim Management,QMS Setup & Remediation, GMP & GxP

A quality system that is too heavy, too thin or under injunction puts production and market access at direct risk. BIO15PHARMA builds quality systems from the ground up, streamlines the ones that have grown unworkable and remediates the findings that have stopped production, so you return to release and market without delay.

Who it is for

Manufacturers in pharma, biotech, medical device, cosmetics and chemical sectors that need to set up a QMS, simplify a heavy one, or remediate findings after an inspection or audit.

What we deliver

•     QMS design and implementation, up to GMP and ISO 9001 or ISO 13485 readiness

•     Remediation of FDA, ANSM and ANVISA observations and injunctions, so you can resume production, release and marketing

•     Clearing of deviation and discrepancy backlogs raised in inspections or audits

•     Change management that makes the QMS robust, consistent and usable

•     Continuous improvement of your quality system

•     Remote inspection management

Proof

A track record of lifted ANSM, FDA and ANVISA injunctions, a founder with 14 years inside major pharmaceutical groups, and a network of 3,600+ experts mobilisable within 24 hours.

Standards

GMP, GxP, ICH, ISO 9001, ISO 13485.