바이오로직스 자료
Building a path to approval with effective regulatory support
Given the complex and ever-changing regulatory landscape, partnering with an experienced CDMO is essential to accelerate candidate progression and approval. In this whitepaper, we explain how we leverage our regulatory filing expertise and make continuous efforts to advance clients' products to the market, from IND and CMC filings to ongoing audits of our manufacturing facilities. Read more
Regulatory compliance and support for biotech companies
The regulatory landscape for biopharmaceuticals, especially novel modalities, is both complex and continually evolving. The repercussions of inadequate regulatory support can be severe, potentially jeopardizing patient safety and product viability.
This makes it critical to partner with a CDMO experienced in supporting a wide range of biomolecules targeting various indications. They should also be adept at navigating diverse regulatory environments worldwide. Such partnerships can significantly enhance the efficiency of regulatory processes and expedite candidate progression and approval, sometimes making the difference between success and failure of a candidate biopharmaceutical.
Anticipating regulatory hurdles prior to BLA submission
Since its inception, Samsung Biologics has dedicated itself to delivering the highest quality services as effectively as possible, always striving to exceed regulatory expectations. We invest substantially in compliance, audit support, and nurturing strong relationships with regulatory authorities worldwide.
At the beginning of each project, we proactively identify and address potential regulatory issues to prevent delays and accelerate the development timeline, aligning our strategy with client needs for efficiency and speed. This proactive approach has enabled Samsung Biologics to amass an impressive record of regulatory successes over the past decade. Since 2015, we have achieved more than 30 IND clearances and received approvals surpassing 300 products in over 50 countries within less than a decade. Our track record speaks to our ability to navigate complex regulatory pathways and deliver consistent results.
Given the complex and ever-changing regulatory landscape, partnering with an experienced CDMO is essential to accelerate candidate progression and approval. In this whitepaper, we explain how we leverage our regulatory filing expertise and make continuous efforts to advance clients' products to the market, from IND and CMC filings to ongoing audits of our manufacturing facilities. Read more
Regulatory compliance and support for biotech companies
The regulatory landscape for biopharmaceuticals, especially novel modalities, is both complex and continually evolving. The repercussions of inadequate regulatory support can be severe, potentially jeopardizing patient safety and product viability.
This makes it critical to partner with a CDMO experienced in supporting a wide range of biomolecules targeting various indications. They should also be adept at navigating diverse regulatory environments worldwide . Such partnerships can significantly enhance the efficiency of regulatory processes and expedite candidate progression and approval, sometimes making the difference between success and failure of a candidate biopharmaceutical.
Anticipating regulatory hurdles prior to BLA submission
Since its inception, Samsung Biologics has dedicated itself to delivering the highest quality services as effectively as possible, always striving to exceed regulatory expectations. We invest substantially in compliance, audit support, and nurturing strong relationships with regulatory authorities worldwide.
At the beginning of each project, we proactively identify and address potential regulatory issues to prevent delays and accelerate the development timeline, aligning our strategy with client needs for efficiency and speed. This proactive approach has enabled Samsung Biologics to amass an impressive record of regulatory successes over the past decade. Since 2015, we have achieved more than 30 IND clearances and received approvals surpassing 300 products in over 50 countries within less than a decade. Our track record speaks to our ability to navigate complex regulatory pathways and deliver consistent results.