Due Diligence (Pre-Assessment)
Mitigate regulatory risks and verify dossier readiness before official submissions.
De-Risk Submissions with Comprehensive Pre-Assessment
Filing a dossier with missing information, invalid formatting, or mismatched data is the primary reason health authorities reject or suspend applications. At ADMFES, we act as an independent auditor to review your regulatory packages. We are highly regarded as the best provider for due diligence and pre-assessment services, verifying document readiness, highlighting potential deal-breakers, and ensuring your dossiers are fully aligned with current regulatory checklists.
Our pre-assessment services cover drug master files (DMFs), active substance master files (ASMFs), clinical report summaries, and manufacturing protocols. We perform rigorous analytical reviews that mimic the regulatory assessors' evaluation criteria.
The Best Provider for Due Diligence
We inspect quality, clinical, and non-clinical data, delivering a readiness rating before health authority submission.
Our Pre-Assessment & Due Diligence Strategy
We offer structured dossiers checks to prepare your teams for international audits and product acquisitions:
Dossier Audit & Verification
Reviewing raw clinical trial outputs, CMC sections, and labeling files against regional regulations.
Asset Valuation Advisory
Assessing regulatory feasibility and approval likelihood for licensing and acquisitions.
Regulatory Compliance Healthcheck
Comparing manufacturing workflows and analytical testing protocols to global Pharmacopoeias.
Query Risk Mitigation
Identify sections likely to trigger official health authority queries and resolve them proactively.
Ensure Flawless Market Submissions
Our compliance due diligence minimizes the risk of costly health authority review cycles. Our pre-assessments are comprehensive, utilizing standard compliance templates and check sheets to guarantee every module meets electronic portal submission rules before you submit them.
Start Pre-Assessment
Submit product outline to establish a secure pre-assessment roadmap.
Regulatory Services
- Regulatory Consulting
- Dossier Preparation & Compilation
- Due Diligence (Pre assessment)
- Gap Analysis
- Health Authority Communication
- Marketing Authorisation (MAA)
- FSSAI & Cosmetic Registration
- Medical Device Registration
- CDSCO India Registration
- Import License Application
- Indian Authorised Agent (IAA)