REGULATORY RECORD OF EXCELLENCE
Apeloa CDMO’s quality systems and regulatory record are a result of a long-term strategic plan to stay at the forefront of quality for contract customers. Contract developers and manufacturers must maintain robust quality systems that can compliantly manage a wide variety of customer product types and projects. Apeloa CDMO is a customer focused service provider that has remained committed to meeting all applicable regulatory and quality requirements, with facilities designed to exceed local requirements.
REGULATORY
Apleoa CDMO has spent over 30 years building robust quality management systems and SOPs that are compliant with major global regulatory requirements. Our success is based in our quality driven policies which can be measured by our track record of positive inspections by customer audit teams as well as major regulatory bodies. Our facilities, staff, and processes adhere to the highest principles of quality and are measurably compliant with current regulations.
REGULATORY ASSURANCE
Apeloa CDMO insists that our scientists, staff, and leaders all adhere to the highest standards of quality. This dedication to quality is visible in the design and maintenance of our state-of-the-art facilities, equipment, and instrumentation. Our staff are highly educated and experienced professionals with a customer service orientation. All of this comes together to produce high-quality practices, SOPs, documentation, and ultimately products or services for our customers.
We maintain our compliance with the latest international regulatory requirements so that our customers can have confidence that Apeloa-manufactured products can be used in virtually any market in the world. Our data and documentation support includes preparation and submission of regulatory dossiers, such as ASMF, CEP, DMFs and we provide our customers with comprehensive CMC support for their filings. With timely international logistics and compliant facilities, Apeloa CDMO provides security of supply to customers no matter where they are.
REGULATORY AUDITS AND ACCREDITATIONS
Our GMP sites have been inspected by highly respected international regulatory bodies, including the U.S. FDA, EDQM, and PMDA, more than 25 times in recent years. The most recent inspections by these agencies were conducted in 2018, 2019, and 2022 respectively. A number of Apeloa CDMO’s manufacturing sites also hold ISO accreditation. We perform document maintenance on a regular basis, which lightens the regulatory/paperwork load and supports a more streamlined document process for customer NDA submissions.
CUSTOMER INTELLECTUAL PROPERTY (IP) PROTECTION
Apeloa CDMO understands the importance of IP ownership to every contract customer. We’ve taken robust measures to protect customer IP so that it remains safe and secure. Every new employee signs a comprehensive confidentiality agreement as a condition of employment. Onboarding training sessions also include an emphasis on how employees can protect customer IP through security measures and best practices. Customer IP is also protected by national law and IP agreements with Apeloa.
Electronic Security and information access are two additional areas used to protect customer IP. Our IT systems require individual confidential authorizations for users to access electronic records securely. Apeloa’s IT systems are all backed up locally, not on third party servers. VPNs and other technologies are used to limit access to Apeloa systems and project information is limited to those on a need-to-know basis. Apeloa monitors all R&D and manufacturing sites via 24/7 CCTV and maintains records of access control with electronic key cards to control individual access to facility areas.