Qualifying

Simplify the Qualification Process with Amicus

In the pharmaceutical industry, being a qualified supplier is critical to gaining and keeping clients. However, the traditional supplier qualification process can be a pain, requiring you to undergo multiple audits from different buyers every week. This constant scrutiny drains your resources and distracts you from focusing on your core business operations.

Amicus is here to ease your pain with the services provided by our Amicus Qualified program. We conduct supplier audits to check that you meet our approval criteria and good manufacturing practice (GMP) requirements so you can join our list of pre-qualified suppliers. This saves you time and resources and makes you more attractive to pharmaceutical, medical device, and FDA-regulated companies.

A pharmaceutical worker handling vials as part of Amicus's supplier qualification program.

Receive Supplier Qualification from a Trusted Company

Amicus Qualified will “qualify” your business as part of our pharmaceutical quality system to evaluate compliance with FDA requirements. We will audit your operations and add you to our list of pre-qualified suppliers, which means your business will be presented to manufacturers as a trusted and verified supplier. You will save time usually spent by undergoing multiple audits, and you’ll be more marketable to manufacturers. When you join our Qualified list, you receive the following benefits:

FDA Compliance Audits

When we perform an on-site audit, our expert auditors evaluate candidates against quality standards to confirm FDA compliance.

Increased Marketability

By simplifying the process, we shorten the time it takes companies to compile candidates and evaluate potential suppliers, improving your chances of being selected.

Trust and Credibility

Amicus is a team of trusted consultants, and with our stamp of approval, you will be seen as a reliable, high-quality supplier.

Singular Qualification

When you join our list of pre-qualified suppliers, Amicus will perform an audit and record the information to give copies to manufacturers who are interested in you as one of their potential suppliers.

Resource Efficiency

Preparing for internal audits takes valuable time and effort, but with Amicus, you can use the time you save to focus on your core business operations.

Ongoing Compliance Support

We will help you stay current with regulatory changes and maintain compliance so you remain an attractive candidate.

The Supplier Qualification Process

Initial Consultation
We start with a full consultation to understand your operations and regulatory requirements.
01
Supplier Information Collection
We collect your documentation and information about your quality systems, compliance history, and operational processes.
02
Audit
Our team will audit your relevant GMP, quality control processes, regulatory compliance, and product quality.
03
Audit Report
We will generate a detailed audit report showing your compliance status, areas for improvement, and recommendations.
04
Supplier Qualification
Once the audit is complete, we will add you to our list of pre-qualified suppliers and promote you to manufacturers as a trusted addition to their supply chain.
05
Re-qualify Suppliers
We continue monitoring suppliers' compliance status and evaluating regulatory standards for the duration of our partnership.
06

Frequently Asked Questions

You’ll be more visible and credible to top pharmaceutical companies, you won’t have to undergo multiple audits from different sources, and you’ll be more attractive as a supplier.

We qualify suppliers of drug products, raw materials, syringes, printed packaging materials, and other components for the pharmaceutical and medical device industries.

Our audits are conducted by experts with in-depth knowledge of FDA regulations, patient safety, and pharmaceutical quality systems, so they are comprehensive and accurate.

Re-audits are scheduled based on the risk level of your operations and changes in regulatory requirements so you remain compliant and a quality supplier.

We offer ongoing monitoring and support to help you stay up to date with regulatory changes and maintain your qualified status.

Join Amicus Qualified!

Become a trusted and verified supplier in the pharma industry. Partner with Amicus to simplify your qualification process, save resources, and gain more business opportunities. Get in touch today to find out how you can join Amicus Qualified and grow your business.

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