Regulatory Support

Submission Preparation & Guidance

Our dedicated, on-site regulatory affairs team provides strategic, data-driven guidance throughout chemistry manufacturing and controls (CMC) operations, establishment of specifications and operating ranges, method development and validation activities, process performance qualification (PPQ), and continued process verification. This ensures the creation, review, submission, and maintenance of all necessary regulatory documentation, providing a tailored approach that meets the needs of your advanced therapy program and the expectations of global health authorities. Our services include:

• Investigational New Drug (IND) application preparation and submission
• Biologics License Application (BLA) preparation and submission
• Marketing authorization approval, amendment, and supplement submission packages
• Briefing document packages

Strong Relationships with Global Regulatory Agencies

By partnering with SK pharmteco for cell and gene therapy development and manufacturing, your program can leverage our strong relationships with global health authorities to expedite regulatory success. Our experienced regulatory affairs team engages in collaborative communications with our partners and regulatory authorities to support the submission and acceptance of advanced therapy applications and documentation. We can guide drug development clients in navigating INitial Targeted Engagement for Regulatory Advice on CBER/CDER ProducTs (INTERACT), pre-IND and pre-BLA meetings, end-of-phase meetings, breakthrough therapy designation meetings, and Type A, B, and C meetings.

Advanced Quality Management System

SK pharmteco has established an automated, globally compliant cell and gene therapy quality assurance program that ensures phase-appropriate compliance and commercial readiness for our development partners’ advanced therapy programs. Our advanced, integrated data infrastructure provides a fully digital footprint throughout development and manufacturing, giving our clients a transparent view into every step of every process. Real-time data capture, electronic batch records, and predictive analytics enable our teams to track critical process parameters, securely maintain chain of identity, and continuously optimize our ability to deliver safe, high-quality products. SK pharmteco’s quality program is regularly assessed to maintain compliance with current regulatory guidelines, improve outcomes, and adapt to changes in the cell and gene therapy industry and regulatory landscape.

Commitment to Compliance

All of our purpose-built facilities are compliant with all global regulatory agencies and boast an unparalleled inspection record, with a 100% pass rate at all locations and 22 successful regulatory inspections in the last five years alone. SK pharmteco’s dedication to compliance is fundamental to the success of our cell and gene therapy development partners. Over the past decade, our sites have completed 31 successful pre-approval inspections, demonstrating our capabilities as a reliable manufacturer of safe, high-quality cell and gene therapy products.