Your Success, Our Commitment: Unleashing Potential in Regulatory Excellence and Pharmaceutical warehousing.
Partnering For Success
Our Expertise
Regulatory Affairs and CMC
Your trusted partner for comprehensive regulatory affairs and CMC services within the European Union. Our expert team ensures full lifecycle management, from CMC variations to post-approval commitments, tailored to your product's specific needs. We excel in CMC compliance and remediation projects, providing in-depth assessments and long-term strategies for pharmaceutical manufacturing standards. Our services extend to change control procedures, technical writing, and efficient CMC documentation.
Medical Device Regulation
Proactive in regulatory intelligence, we keep clients abreast of evolving regulations, providing strategic insights for adaptation and compliance. With expertise in technical documentation, we assist in writing and reviewing documents, minimizing regulatory review risks. Our comprehensive support extends to CE conformity assistance, guiding through the assessment process. We also help align Quality Management System activities with EN ISO 13485, ensuring effective compliance.
Warehousing and Product Release
Tailored importation and warehousing services, ensuring compliance with Good Distribution Practice (GDP) and providing Qualified Person (QP) expertise. Our warehouse feature temperature-controlled storage, robust inventory management, and security systems. Serving as a site of physical importation, our team handles entry processes with precision. QP services provide confidence in compliance. Offering flexible short-term and long-term storage solutions, we collaborate closely with clients to meet unique requirements.
Let’s Talk
Send us a message in the contact form or via any of the below contact points. We are happy to hear from you!
Telephone: 00316 85238946
Email: info@aspectpackaging.com