Regulatory Services
Regulatory deficiency and query handling
A deficiency letter is a request for clarity, not necessarily a rejection — but a vague or incomplete answer can lead to further rounds or refusal. We help you understand exactly what the authority is asking, gather the right evidence and respond completely, on time.
- Typical queries Quality, stability, impurities, BE, labelling, administrative
- Typical inputs Deficiency letter, dossier, technical data
- You receive Response document and updated dossier sections
Overview
About Deficiency & Query Handling
Queries often combine scientific, technical and administrative points. Some can be answered with existing data; others need new data, a justification or a commitment. The quality of the response depends on understanding the reviewer’s concern and answering it directly.
We interpret each point, agree a response strategy with you, coordinate input from your technical teams and our toxicologists, and draft a response that is clear and easy to verify.
Use cases
When this service helps
Quality and CMC queries
Specifications, impurities, stability or process questions.
Toxicology and safety questions
Impurity qualification, nitrosamines or E&L concerns.
Bioequivalence queries
Questions on study design, analysis or waivers.
Administrative and labelling points
Certificates, forms and product information.
Scope
What the service covers
- Interpretation of each query and the underlying concern
- Response strategy: data, justification or commitment
- Coordination of technical input across teams and partners
- Scientific justifications, including toxicological assessments
- Drafting the response and updating dossier sections
- Tracking deadlines and commitments
Who does what
The applicant submits the response and makes any commitments to the authority. Globaxa prepares the response and supporting documents.
What if new data are required?
If the data cannot be generated before the deadline, it may be possible to request an extension or provide a justified commitment, depending on the authority. We help you decide and document the approach.
Methodology
How we work
A defined sequence, agreed with you at the start, so you always know what happens next and what we need from you.
- Analyse the letterEach point is clarified and classified.
- Plan the responseAgree what evidence or justification is needed.
- Gather evidenceData and assessments are collected or prepared.
- Draft and reviewA complete response is drafted for your approval.
Deliverables
What you receive
Query analysis
A table of each point, its interpretation and the planned response.
Response document
Point-by-point answers with supporting annexes.
Updated dossier sections
Revised modules where the response changes the file.
Technical basis
Guidelines we work to
- Authority proceduresEach authority sets response formats and deadlines in the deficiency letter.
- Relevant ICH and national guidelinesResponses are grounded in the guidelines underlying each query.
What we need from you
- The deficiency letter and deadline
- The submitted dossier (relevant sections)
- Technical data and contacts for each topic
Please share confidential information only after an NDA is in place — we are happy to sign one first.
Market and jurisdiction considerations
Response deadlines and the possibility of extensions vary by authority. Missing a deadline can lead to the application being closed, so we plan the work back from the due date.
FAQs
Deficiency & Query Handling: frequently asked questions
Can you help if the dossier was prepared by someone else?
Yes. We review the relevant sections first so that the response is consistent with the file.
How fast can you respond?
We prioritise query work because deadlines are fixed. Timing depends on whether new data are needed.
Can you reduce the risk of queries in future?
Yes. A regulatory gap analysis before submission identifies likely query areas.
Talk to us about Deficiency & Query Handling
Share your product, target market and timeline. We will review your requirement and propose a defined scope.
- OfficeFlat no 8-9-3/23/1, Subhash Chandra Bose Colony, Dathunagar, Kanchanbagh, Hyderabad, Telangana 500058, India
Open in Google Maps - Phone+91 81219 33381
+91 99894 74590 - Emailbd@globaxa.in
- Office hoursMonday to Friday, 10:00–19:00 IST