Certification

ISO 9001 Certified CDMOs

Compare CDMOs with ISO 9001 quality management system certification. Filter by manufacturing type and regulatory approvals.

1 company listed

About ISO 9001 in Pharmaceutical Manufacturing

ISO 9001 is the international standard for quality management systems (QMS). In pharmaceutical manufacturing, it provides a framework for consistent processes, continuous improvement, and customer focus that complements GMP requirements. While GMP is mandatory for pharmaceutical manufacturing, ISO 9001 certification demonstrates a broader organizational commitment to quality.

ISO 9001 certification requires: documented quality policy and objectives, risk-based process management, internal audit programs, management review, corrective and preventive action systems, and evidence of continuous improvement. Third-party certification bodies audit compliance every 1-3 years.

Companies (1)

ResolveMass Laboratories Inc.

Canada

ResolveMass Laboratories Inc. is a Canadian pharmaceutical CRO and CDMO providing analytical testing, characterization, and drug development support for pharmaceutical, biotechnology, and medical device companies worldwide. Our expertise spans small molecules, peptides, biologics, biosimilars, oligonucleotides, polymers, and complex drug products. We offer specialized services including mass spectrometry (LC-MS/MS, LC-HRMS), peptide characterization, impurity identification, nitrosamine analysis, extractables and leachables (E&L) studies, bioanalytical testing, stability studies, method development, and regulatory support. Our multidisciplinary scientific team helps clients address complex analytical challenges and generate high-quality data to support research, development, manufacturing, and regulatory submissions. ResolveMass Laboratories operates from Canada and serves clients across North America, Europe, and Asia. The company maintains an ISO 9001:2015 certified Quality Management System, is FDA-registered, and holds a Health Canada Drug Establishment Licence for GMP-compliant operations. We are committed to delivering scientifically rigorous, reliable, and timely solutions that accelerate drug development and support regulatory success.

Analytical ServicesStability StudiesMethod Development & Validation

Frequently Asked Questions

Is ISO 9001 required for pharmaceutical manufacturing?+

No, ISO 9001 is not legally required for pharmaceutical manufacturing -- GMP compliance (FDA, EMA, etc.) is the regulatory requirement. However, ISO 9001 provides a complementary quality management framework that many CDMOs adopt to demonstrate organizational quality maturity. Clients often view ISO 9001 certification as a positive indicator of a CDMO's quality culture.

How does ISO 9001 complement GMP?+

GMP focuses on pharmaceutical-specific manufacturing controls (equipment qualification, process validation, batch records, etc.). ISO 9001 provides a broader management system framework covering: strategic planning, resource management, customer communication, supplier management, and organizational learning. Together, they create a more comprehensive quality system than either alone.