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Quality & Regulatory

At Orchestra Life Sciences, we pride ourselves on delivering comprehensive Quality, Compliance, and Regulatory Affairs services to our clients. Patient safety, and drug efficacy; the mission of the U.S. FDA, paired with a right first time, and intentional quality assurance mentality forms the cornerstone of our approach. Ensuring that products reliably, accurately, and reproducibly meet stringent ethical standards.

Our team of experts meticulously assesses manufacturing processes, conducts audits, and implements quality management systems to uphold the highest standards throughout the product lifecycle. In parallel, our Compliance specialists navigate the complex landscape of regulatory requirements, providing strategic guidance and practical solutions to ensure full adherence to all applicable laws and regulations. From FDA compliance, further encompassing international standards, such as the International Council for Harmonisation (ICH), we offer tailored support to safeguard our clients’ operations and reputation. Furthermore, our Regulatory Affairs services and strategies help our clients navigate the intricate maze of regulatory approvals and submissions, facilitating timely market access for novel and complex ATMP products. With our dedicated expertise and unwavering commitment to excellence, we empower pharmaceutical companies to navigate regulatory challenges, maintain compliance, and achieve their business objectives with confidence.

We offer a comprehensive suite of services tailored to the evolving needs of the sector. From nuclear medicine, radioligands, biotechnology, and cutting-edge therapies like cell and gene, our expertise spans the entire spectrum of healthcare innovation.

List of examples of type of work we can do in this group:

Review, authorship, for submission of agency documentation, ie. IND, IMPD, BLA, Amendments,
Quality Audits (GMP) of Supplier, Vendors and Service providers for materials managment
Internal quality audits such as mock FDA inspections for compliance and gap assessments/risk assessments
Quality Remediation
Build out regulatory pathways and strategies

Establish Quality management departments in new startups (i.e. pharmaceutical quality System ICH Q10)
Executive training
Implement and build out software QMS solutions
Data Integrity programs and policies
Training
Validation services