Nikki Pavlides is a highly accomplished biopharmaceutical process expert and the Owner of CenterPoint CMC Solutions, where she leverages over 15 years of extensive experience in the biotechnology industry. Her current role involves collaborating with clients across the biotech, pharmaceutical, and medical device sectors, guiding...
Nikki Pavlides is a highly accomplished biopharmaceutical process expert and the Owner of CenterPoint CMC Solutions, where she leverages over 15 years of extensive experience in the biotechnology industry. Her current role involves collaborating with clients across the biotech, pharmaceutical, and medical device sectors, guiding them through every stage of the product pipeline—from pre-Investigational New Drug (IND) applications to post-marketing surveillance. Nikki’s expertise in regulatory project management and submission authoring is complemented by her comprehensive understanding of Chemistry, Manufacturing, and Controls (CMC) operations.
At CenterPoint CMC Solutions, Nikki has spearheaded key projects that focus on regulatory compliance and quality assurance, ensuring that clients meet stringent industry standards while navigating complex regulatory landscapes. Her proficiency in technical project management encompasses critical areas such as investigations, quality remediation, change controls, and process improvements. Nikki’s commitment to excellence is evident in her ability to manage issues effectively and streamline processes, which significantly enhances operational efficiency for her clients.
With a Regulatory Affairs Certification and a deep understanding of drug discovery, purification processes, and vaccine development, Nikki is adept at addressing the unique challenges faced by her clients. Her strong communication skills further enable her to foster collaborative relationships, ensuring that all stakeholders are aligned and informed throughout the regulatory journey. As a thought leader in the field, Nikki is dedicated to driving innovation and compliance in the biopharmaceutical landscape, making her an invaluable asset to any organization seeking to navigate the complexities of regulatory affairs.
