Controlled Correspondence Assistance
Masuu US Agent assists pharmaceutical companies in drafting, reviewing, authorizing, submitting, and obtaining approval from USFDA for Controlled Correspondence (CC) submissions, a process for generic drug manufacturers to request information related to generic drug development before submitting an ANDA.
Masuu has filed a wide array of Controlled Correspondence including.- Q1/Q2 sameness with Reference Listed Drug (RLD)
- Chemistry Questions, RS Designation
- MDD of Drug Product
- Alternative BE Approach
- Bioequivalence Questions
- Inactive Ingredients, Formulation/Overage
- Device Evaluation, Guidance Clarification
- Drug Shortage
- RLD Assignment/Availability/Status
- Retention Samples, Labeling Questions
- Combination Products
- Dissolution Specification
- Filing, and more.
Trust us to streamline your regulatory communication process and ensure clarity and compliance every step of the way.