Smart Manufacturing Helps Your Business


Why Anteco Pharma?

  • Facilities and process control systems.
  • Cost effective and time efficient.
  • A focus on you.
Anteco Pharma is ISO 9001:2000 and ISO 13485:2003 Certified

Compliance and Quality System

It's about meeting — and exceeding — expectations.

We begin every project by carefully assessing your budget, timelines, and overall business objectives. Then we align those expectations with the highest quality standards, including technical excellence, innovation, and service. This now includes the international recognition of ISO 9001 and ISO 13485 certifications.

We also meet the lofty standards of the regulatory agencies in the sectors in which we operate. We're constantly monitoring these requirements, and refining our facilities, systems and approach to ensure we are compliant to all new developments. You don't have to worry about compliance when you partner with Anteco Pharma. The many types of compliance and regulatory standards we incorporate and monitor include:

  • US FDA Drug registration
  • US FDA Medical Device registration
  • Kosher Certification
  • Food manufacturing license
  • ISO 9001:2000 and ISO 13485:2003 (medical device) certification
  • 21 CFR Parts 210 and 211 (drug cGMP)
  • 21 CFR Part 820 (medical device cGMP)
  • 21 CFR Part 111 (nutritional supplement cGMP)

Finally, we have set our own rigorous standards. Knowing the demands of these industries, we set the bar higher in every phase of our operation. We're continuously seeking improvement, building on the skills of our people, and the capabilities of our facilities.