What's the difference between CTD and ACTD formats?
The CTD (Common Technical Document) is the standard for most major markets like the US and EU, while the ACTD (ASEAN CTD) is tailored for Southeast Asian countries. Both structure regulatory information into modules, but they have key differences in layout and regional requirements. We're experts in both.
How do you help with CDSCO device registration in India?
We manage the entire process for you. This includes correctly classifying your device (from Class A to D), preparing all technical files and labeling for compliance, and submitting everything according to India's MDR-17 rules.
What is a CEP, and how is it different from a DMF?
A CEP (Certificate of Suitability) confirms that your API meets European Pharmacopoeia standards, which is great for the EU market. A DMF (Drug Master File) is a more detailed, confidential filing for agencies like the FDA and Health Canada. We can help you decide which is right for you and prepare the submission.
What documents are needed for a bio-waiver request?
To waive in-vivo bioequivalence studies, you need a solid scientific case. We help build it with dissolution profiles, BCS classification data, and a clear clinical justification, which is especially useful for BCS Class I & III drugs.
Do you handle responses to regulatory questions?
Absolutely. We prepare professional response packages that include scientific justifications, updated documents, and remediation plans that directly address the agency's concerns and expectations.
Can Indivirtus act as our Qualified Person (QP) in the EU?
Yes, through our network, we provide QP declaration services. We can also act as your MAH representative and arrange for EU-based testing sites to facilitate batch releases, making your entry into the EU market much smoother.
What does CTD/ACTD dossier preparation involve?
We handle the entire compilation of Modules 1–5 for either CTD or ACTD formats. This includes all administrative, quality, non-clinical, and clinical data. We also perform a gap analysis, adapt content for local markets, and publish it in eCTD/NeeS formats for submission.
How do you support medical device registration under MDR-2017?
We guide you through every step: device classification, preparing the Technical Documentation File (TDF/CSDT), creating clinical evaluation reports, managing risk files, and handling all submissions (MD-7/MD-14/MD-15) to CDSCO to ensure full compliance.
What is the role of an MAH or QP in the regulatory process?
Our MAH (Marketing Authorization Holder) services manage your regulatory responsibilities in the EU/UK. Our Qualified Person (QP) services are essential for batch release, import testing, and ensuring compliance for both clinical trials and marketed products.
How do you manage regulatory responses and remediation?
When you receive a query like an FDA 483 or EU Letter of Questions, we step in. We prepare strategic responses, manage Corrective and Preventive Actions (CAPAs), and support audit remediation to resolve compliance gaps swiftly.
Which industries benefit most from your regulatory services?
We primarily support pharmaceutical manufacturers, biotech firms, medical device companies, and Marketing Authorization Holders who need help achieving global regulatory approvals and maintaining their compliance.
What is your process for DMF/CEP filing?
We prepare and submit all types of DMFs (Type I–V) and CEPs to global agencies like EDQM, FDA, or Health Canada. Our service includes preparing both the open and restricted parts, managing annual updates, and providing full support for any agency queries.
