Global Regulatory Expertise. Precision Execution.
From first DMF submission to complex eCTD conversions — we navigate every regulatory pathway with 30+ years of hands-on experience across FDA, EMA, and ICH frameworks.
Submission Types & Formats
We prepare and manage regulatory dossiers across all major submission types and formats — for FDA, EMA, EDQM, and ASEAN regulatory authorities.
Drug Master File
Type II (API) and Type IV (Excipient) DMF preparation and lifecycle management for FDA.
Certificate of Suitability
EDQM CEP applications for APIs and excipients with full Ph. Eur. compliance.
Active Substance Master File
ASMF preparation for EMA submissions with applicant and restricted parts.
Investigational New Drug
IND application preparation and FDA liaison for clinical trial authorization.
New Drug Application
Full NDA dossier compilation in eCTD format with complete Module 1–5 documentation.
Abbreviated New Drug Application
Generic drug ANDA preparation including bioequivalence and labeling requirements.
Biologics License Application
BLA dossier preparation for biological products and biosimilars.
Marketing Authorization Application
EMA MAA dossier in CTD/eCTD format for centralized and national procedures.
505(b)(2) Application
Hybrid applications relying on published literature or prior FDA findings.
ASEAN Common Technical Dossier
ACTD format submissions for ASEAN regulatory authorities.
eCTD Publishing & Portal Management
End-to-end eCTD services from conversion and publishing to portal setup and annual registration — ensuring your submissions are technically compliant and on time.
eCTD Conversion
Full conversion of paper and NeeS dossiers to eCTD format at document and submission level.
eCTD Publishing
Compliant eCTD publishing and validation against FDA, EMA, and ICH M8 specifications.
Portal Setup
ESG, CESP, CDER Direct, and Next Gen. portal configuration and account management.
DUNS & FEI Registration
DUNS Number, FEI Number, GDUFA self-identification, and annual establishment registration.
NDC Code Assignment
Structured Product Labeling (SPL) preparation and NDC code assignment for all dosage forms.
Lifecycle Management
Post-approval change management, annual reports, and submission sequence maintenance.
Unparalleled Impurity Expertise
Our DMF section control expertise covers the most technically demanding aspects of API regulatory submissions — from starting material justification to genotoxic impurity management.
Starting Material Selection
Regulatory justification for starting material selection and redefinition for synthetic APIs per ICH Q11.
Specification Justification
Rigorous justification of specifications aligned with ICH Q6A/Q6B and pharmacopoeial standards.
Organic Impurities
Identification, characterization, and qualification of organic impurities not listed in monographs.
Nitrosamine Risk Management
Comprehensive nitrosamine risk assessment, control strategies, and regulatory response per FDA/EMA guidance.
Elemental Impurities
ICH Q3D-compliant risk assessments, control strategies, and specification setting for DMF filing.
Genotoxic Impurities
Assessment and control of genotoxic and mutagenic impurities per ICH M7 guidelines.
Polymorphism & Particle Size
Polymorphic form characterization and particle size distribution control strategy development.
Residual Solvents
ICH Q3C-compliant residual solvent evaluation, classification, and specification justification.
How We Work
Assessment
We review your existing documentation, identify gaps, and define the regulatory pathway.
Strategy
A tailored submission strategy is developed — format, timeline, authority, and risk mitigation.
Compilation
Full dossier preparation with technical writing, data review, and quality checks at every module.
Submission
Publishing, validation, portal submission, and post-submission query management.
Plan Your Next Submission
Whether you're filing a first DMF or managing a complex multi-market submission strategy, we bring the technical depth and regulatory precision to get it right.