Quality and Regulatory
Services at Dhee Lifesciences: Ensuring Compliance and Excellence
Dhee Lifesciences is a leading provider of quality and regulatory services, committed to ensuring compliance and excellence in pharmaceutical development. Our comprehensive suite of services includes CTD filings, dossiers that meet diverse global requirements, IND/NDA and ANDA support documentation, post-approval changes, and related regulatory filings, as well as licensing support. With a focus on quality, safety, and efficacy, we help our clients navigate the complex regulatory landscape and bring their products to market efficiently and effectively.
CTD Filings:
Our team of regulatory experts is well-versed in preparing Common Technical Document (CTD) filings for regulatory submissions. We ensure that all sections of the CTD, including quality, nonclinical, and clinical data, are compiled accurately and in compliance with regulatory guidelines. Our meticulous approach ensures that our clients’ submissions are comprehensive and of the highest quality.
Dossiers that Meet Diverse Global Requirements:
We understand the importance of meeting diverse global requirements for regulatory submissions. Our regulatory team is experienced in preparing dossiers that comply with the regulations of various regulatory authorities, including the FDA, EMA, and PMDA. Whether it’s formatting requirements or specific content requirements, we ensure that our dossiers meet the standards of each regulatory authority.
IND / NDA and ANDA Support Documentation:
We provide comprehensive support for Investigational New Drug (IND), New Drug Application (NDA), and Abbreviated New Drug Application (ANDA) submissions. Our team assists in preparing the necessary documentation, including preclinical and clinical data, to support these submissions. We also provide guidance on regulatory strategy and help our clients navigate the regulatory process.
Post Approval Changes and Related Regulatory Filings:
Our regulatory team is well-equipped to handle post-approval changes and related regulatory filings. Whether it’s a manufacturing change, labeling update, or post-market surveillance requirement, we ensure that our clients’ submissions are prepared accurately and submitted in a timely manner.
Licensing Support:
We provide licensing support to help our clients secure the necessary licenses for their pharmaceutical products. Our team assists in preparing the required documentation and liaises with regulatory authorities to facilitate the licensing process. We also provide ongoing support to ensure compliance with licensing requirements.
At Dhee Lifesciences, we are committed to excellence in quality and regulatory services. Our experienced team of regulatory experts works closely with our clients to understand their specific needs and develop tailored solutions to meet them. With our comprehensive suite of services, we help our clients navigate the regulatory landscape and bring their products to market successfully.