Full Lifecycle Management and Maintenance Across the EU

We offer a range of services to support pharmaceutical companies throughout the product lifecycle. This includes CMC variations, renewals, de-registrations, and handling post-approval commitments. We understand that each product has specific requirements, and our team is ready to navigate the regulatory landscape to ensure compliance and successful outcomes.

In addition to CMC activities, our translation activities help clients effectively communicate their regulatory submissions in multiple European languages. Through our reliable network of linguists and translators, we offer accurate and compliant translations for regulatory documentation.

CMC Compliance and Remediation Projects

At Aspect Packaging, we understand the importance of CMC compliance in the pharmaceutical industry. Our team has years of experience working on compliance and remediation projects, assisting clients in resolving issues related to chemistry, manufacturing, and controls. We provide  in-depth assessments, identify gaps in compliance, and offer tailored solutions to achieve regulatory compliance. Our focus is not just on corrective actions but also on developing long-term strategies to maintain compliance and uphold the highest standards in pharmaceutical manufacturing.

Change Control Procedures, Technical and CMC Writing

Change control is an essential aspect of maintaining regulatory compliance in the pharmaceutical industry. Whether it's a change in manufacturing processes, suppliers, or specifications, our team ensures that the required CMC documentation is prepared accurately and efficiently. We understand the intricate details involved in CMC writing and can assist in generating comprehensive and streamlined documents