Global quality and regulatory support for cell and gene therapy 

Our global quality and regulatory teams will support your project at every stage – from pre-IND to the marketing authorization of your cell and gene therapy (CGT) products. With our experience in more than 50 countries over 30 years, we have all the know how to accelerate your regulatory submissions.

Gene and cell therapy project phases.

Let’s make your submission successful

We are your experienced partner to take your CGT product from bench to clinical trials and beyond. We have supported numerous clinical trials to successfully transition to pivotal trials and marketing authorizations. This includes even early steps, for an easy transition from process development to clinical trial approval. To support your needs worldwide, we have highly dedicated quality and regulatory teams that are ready to work closely with you for a smooth integration or our product information into your submission.

Global map with marked countries of regulatory support.
Our Regulatory Support Files and Biologics Master File are acknowledged in more than 21 countries.

Regulatory services for lentiviral vectors

With us, you can get regulatory packages and services for lentiviral vectors that support you on your path to IND and market approvals, including cross reference letters for Biologics Master Files (BMF) with US Food & Drug Administration (FDA) and Health Canada. For regions without an equivalent BMF mechanism, we prepare additional documents such as Regulatory Support Files (RSFs) to support your regulatory submissions.

Regulatory services for cell therapy

Meeting chemistry, manufacturing, and controls (CMC) requirements is essential for a successful regulatory submission. Our cell therapy manufacturing platform, including process components, are supported by Master Files to meet CMC requirements. Part of the Master Files are complete process mappings and descriptions, as well as protocols and reports for process qualification, assay qualification, aseptic process qualification, and storage and stability reports. For countries where the Master File system is not used, we have established Product Information File (PIF) systems for all raw materials for the manufacturing of CGT products. PIFs are a concise regulatory summary of non-confidential information to support your clinical trial submission. For your marketing authorization, we support you with Regualtory Support Files (RSFs, confidential information) to finalize your submission.

All documentation in one place – MACS® GMP Products

For the manufacture of your cell therapy product, most raw materials are part of the MACS GMP Portfolio. MACS GMP Products are manufactured and tested under a quality management system (ISO 13485) and comply with the relevant GMP guidelines. They are developed in accordance with USP <1043> on ancillary materials. Our product-specific documentation packages include information such as package inserts, lot-specific Product Quality Certificate (PQC), Product Information File (PIF) and/or Master File cross reference for select products, Certificates of Origin (CoO), or TSE/BSE statement. We work with you to ensure that all documents are in the right place and of the quality required for your successful exchange with regulatory authorities.

Let’s talk about how we can help you