In the pharmaceutical industry, pharmaceutical life cycle management is a critical component to ensure the safety and efficacy of products. Our regulatory affairs team is well-versed in post-approval chemistry, manufacturing, and controls (CMC) and pharmaceutical life cycle management OR Drug Life cycle management, and we have experience in obtaining various types of regulatory submissions, such as Abbreviated New Drug Application (ANDA), New Drug Submission (NDS), Marketing Authorization Application (MAA), and New Drug Application (NDA), as well as new product authorizations for finished products and APIs.

Our team is equipped to handle health authority queries and interactions, as we understand the importance of maintaining compliance with regulatory agencies. We stay up-to-date with the latest regulatory requirements and updates, and our expertise allows us to ensure that your pharmaceutical products meet the necessary standards for safety and efficacy throughout their lifecycle.

The pharmaceutical industry is constantly evolving, and keeping up with the changes can be a challenge. That’s where RABT comes in. Our regulatory affairs team has years of experience in the industry, and our team is dedicated to providing exceptional support to our clients. We understand the complexities of the regulatory process and are committed to ensuring that your products are compliant with all regulatory requirements.

RABT provides unparalleled regulatory affairs services that will help your pharmaceutical products succeed in the marketplace. With our expertise, you can focus on what you do best – developing innovative pharmaceutical products that improve patients’ lives. Contact us today to learn more about how we can support your Pharmaceutical Life Cycle Management or drug Life Cycle Management needs.

RABT Life Cycle Management Expertise:

• Abbreviated New Drug Application (ANDA)
• New Drug Submission (NDS)
• Marketing Authorization Application (MAA)
• New Drug Application (NDA)
• New product authorizations for finished products and APIs
• Post-approval chemistry, manufacturing, and controls (CMC)
• Health authority queries and interactions