A small business supplier to the pharmaceutical and medical device industry was getting overwhelmed with demands that they be compliant with ISO, with cGMPs, and with 21 CFR 11. We defined a defensible strategy for compliance using ISO and elements of compliance with Part 11, and then showed them how and why they did not need to comply with 21 CFR 11 or any of the FDA regulations, especially given the recent FDASIA 2012 law. Adopting ISO and industry best practices for data integrity and data privacy were perfect for this small supplier. As a result, our client was able to push back on their prospective customers – and win their business and their respect.
“Cerulean provided us with intelligent regulatory guidance that allow our business to showcase its compliance and remain competitive within our industry. They understood our objective and did not try to sell us other compliance consulting services.”
– Jill Balcerzak, Director of Organizational Development & Quality, East Hartford, Connecticut
Critical to providing competitive materials and services to FDA-regulated industries is knowing how to find a balance between what a prospective customer says they need versus what you can provide and stay in business. Be aware that while pharma and device firms will try to push as much compliance responsibility off on their suppliers, ultimately – whether dealing with the FDA or the EMA – the supplier is usually not accountable to the regulators.
If you’re looking for intelligent supplier management and an FDA supplier expert you can trust to help you find the balance between compliance and profitability, get Cerulean.