GOALS

• Ensure all packaging materials and processes adhere to stringent quality standards and regulatory guidelines
• Minimize the risk of product contamination, damage, or counterfeiting through secure and traceable packaging solutions
• Establish strong relationships with reliable packaging partners who prioritize quality and compliance.

Frustrations

• Encountering packaging defects or inconsistencies that could compromise product quality and safety, leading to costly rework or recalls
• Staying up-to-date on evolving regulatory requirements and ensuring packaging compliance remains a constant challenge
• Lack of transparency and communication from packaging suppliers raises concerns about quality control and potential risks.

GOALS

• Successfully launch new drug products on time and within budget by securing efficient and compliant packaging solutions
• Coordinate seamlessly with packaging suppliers to ensure smooth integration of packaging into overall project timelines
• Navigate the complexities of ANDA and NDA submissions by collaborating with knowledgeable packaging partners who can provide regulatory support.

Frustrations

• Unexpected delays from packaging suppliers can derail project timelines and impact critical product launch dates
• Miscommunication or lack of coordination with packaging vendors leads to inefficiencies and delays in the development process
• Limited knowledge of regulatory requirements for packaging within the team creates roadblocks and slows down the submission process.