Compliance and Regulatory Support

The foundation of Ascend Laboratories SPA’s success lies in our comprehensive regulatory and compliance services. Our Regulatory team expertly manages the creation, review, and submission of essential documentation, while our Compliance group oversees our Factory Compliance Programs, CMO management, and facility inspections.

Factory Compliance Programs

Ascend Laboratories SPA’s Factory Compliance Programs ensure ongoing compliance within our Contract Manufacturing Organizations (CMOs). We achieve this by educating our manufacturing partners on the requirements of the FDA and the critical importance of data integrity.

Six System +1 Factory Audit

This audit is meticulously designed to reflect the FDA inspection process. We have tailored the FDA’s template to include an on-site follow-up and training component, ensuring that the Corrective Action Preventative Action (CAPA) plan is properly implemented.

Three-Phase Factory Evaluation

To verify that our CMOs maintain the necessary systems, we assess their internal audit processes. We provide detailed feedback and training to address and correct any identified deficiencies.

cGMP Seminar Series

Annually, we host a two-day conference where all our manufacturers gather to discuss various aspects of cGMP. This seminar enhances participants’ understanding of quality and compliance requirements, fostering an environment of continuous improvement.

Regulatory Filings

Ascend Laboratories SPA has filed over 200 DMFs, eDMFs, and Certificates of Suitability (COS) in key markets including the United States, Europe, Canada, Australia, Japan, Korea, and New Zealand.

We have achieved over 45 first-to-market generic approvals.
Since 2010, we have completed more than 500 regulatory filings in over 20 countries.
Ascend Laboratories SPA is ranked #1 in DMFs Available for Reference among API companies globally, with 65 DMFs for reference.

FDA Approvals

Ascend Laboratories SPA boasts a track record of over 120 successful inspections by the FDA over the past 15 years, underpinning a robust 40+ year relationship with the agency.
Our facilities have passed over 200 customer audits in the last five years alone.

From meticulous factory selection to routine audits and quality checks, Ascend Laboratories SPA takes a proactive approach with our manufacturing partners. This ensures the consistent production of high-quality pharmaceutical-grade APIs. Our facilities adhere to ICH Guidelines and are WHO compliant, cGMP qualified, and USFDA approved. This guarantees that your Finished Dosage meets all regulatory criteria and is effective in markets worldwide.