When you choose DPT for your contract pharmaceutical development and manufacturing needs, you can rest assured you’ve chosen a partner that is committed to the highest quality standards. Our Regulatory Compliance and quality teams will work closely with you to monitor all key activities, anticipate your needs and collaborate on solutions to your concerns.
A comprehensive set of standard operating procedures guides all key activities and keeps us compliant with regulations from U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and foreign markets. Our focus on continuous training and investment in quality systems helps ensure that products developed and manufactured at DPT meet the highest quality standards.
Taking a proactive approach to training and continuous improvement ensures DPT is fully aware of regulatory evolutions in guidance and enforcement. Up-to-date knowledge is essential for companies to maintain compliance with regulatory standards in all the markets in which they operate.
Our outstanding regulatory compliance history serves as a strong foundation for our organization. The Regulatory Compliance staff has more than 45 years of combined experience in the pharmaceutical manufacturing and regulatory affairs arena. Our staff provides oversight of regulatory compliance by administering an effective internal audit program.
The compliance team also provides experienced support of regulatory and client inspections and vendor auditing activities. Our highly skilled regulatory specialists can support your regulatory submissions with the FDA, EMA and overseas regulatory agencies.