Such discussion to help the reviewers becomes acquainted with the information to be included in the NDA. 4. In case the sponsor intends to seek exemption of local clinical trial, clear request for the same should be made in the NDA alongwith rationale and justification and the relevant regulatory provision, under which the exemption is sought. 5. Similarly, in case the sponsor intends to seek app ...

Medical licenses are regulatory licenses issued to individuals, such as doctors, nurses, pharmacists, and other healthcare professionals, allowing them to practice medicine and provide healthcare services legally and safely. These licenses are granted by government authorities or medical boards at the state or national level and are crucial for ensuring the competence and ethical standards of heal ...

We have a young professional team working on regulatory submissions for pharmaceutical products and other client-specific projects. We pride ourselves in having first-hand knowledge of drug regulatory rules etc. and keep ourselves updated all the time.