We offer an agile and comprehensive partnership in life sciences. Our services are designed to support medical device regulation, regulatory affairs, and Chemistry, Manufacturing, and Controls (CMC) outsourcing for pharmaceuticals.
Partnering For Success
Regulatory Affairs and CMC
We can partner for comprehensive regulatory affairs and CMC services within the European Union. Our team can ensure 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.
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.
Medical Device
Regulation
We provide proactive regulatory intelligence, keeping clients updated on changing regulations and offering strategic insights for compliance. Our expertise includes writing and reviewing technical documentation to minimize regulatory risks. We offer comprehensive support for CE conformity and guide Quality Management System alignment with EN ISO 13485 for effective compliance.
Let’s collaborate
We will reply within 12 hours.
For urgent matters you can phone: 00316 85238946
Email: info@aspectpackaging.com