Small Molecule Regulatory Services

SK pharmteco’s experienced team of pharmaceutical regulatory consulting service experts can help clients build a clear and efficient regulatory strategy, investing energy in goal-appropriate and phase-appropriate activities while avoiding common pitfalls and delays. We maintain robust quality assurance programs and continuously monitor changes in global regulatory requirements, taking a proactive approach to help clients address issues before they become significant hurdles in the approval process. Additionally, we assist clients in preparing documentation for regulatory submission, ensuring that it is complete, accurate, and fully compliant, helping to streamline the review process and accelerate approval.

Several areas of SK pharmteco’s expertise are particularly relevant for helping small molecule clients navigate development pathways. First, our extensive breadth of knowledge in current global regulatory standards can inform the development of an appropriate regulatory strategy. This goes beyond ‘checking boxes’ — we help clients build a phase-appropriate approach that meets or exceeds all necessary parameters for compliance while staying efficient. Additionally, our depth of expertise enables us to anticipate future regulatory demands and craft a foundational strategy accordingly, ensuring that later-phase needs are never treated as an afterthought. Finally, our extensive capabilities in process and analytical method development, combined with our commitment to quality and compliance, offer small molecule clients the widest possible toolbox in developing processes that yield consistent, safe, high-quality drug substances and products.

We can help small molecule clients understand necessary requirements and prepare the documentation required for regulatory submissions at every development stage, including NDAs, MAAs, IND applications, and DMFs in support of supply into global markets. SK pharmteco can also guide clients in establishing CMC activities for small molecule products and providing the necessary data and documentation to prepare CMC sections of regulatory submissions.

SK pharmteco has established itself as a leader in regulatory affairs services within the small molecule manufacturing landscape by building and maintaining strong relationships with global regulatory agencies and committing to a culture of quality and operational excellence. This goes beyond an intimate understanding of current regulatory requirements. Our sites have trained over 200 U.S. FDA personnel and have a strong track record of successful inspections from global regulatory agencies. We’re dedicated to ongoing initiatives to strengthen the pharmaceutical development and manufacturing landscape.