30+ Years of
Regulatory
Excellence
Comprehensive Regulatory Affairs and cGMP/GxP Compliance Consulting for pharmaceutical, biotech, biosimilar, and medical device organizations — globally.
Comprehensive Regulatory Solutions
Eleven integrated service areas covering every dimension of pharmaceutical regulatory compliance — delivered under one roof.
Regulatory Affairs / Compliance
Dossier compilation in CTD, ACTD, NeeS, and eCTD formats for DMF, CEP, IND, NDA, ANDA, BLA, MAA, and 505(b)(2) submissions.
Drug Master File, ACTD, CTD & eCTD
End-to-end DMF preparation, eCTD conversion, publishing, and submission management at document and report level.
Quality Assurance / Control
Comprehensive QA/QC systems aligned with cGMP and GxP standards.
Product Development
API and formulation development support from concept to commercialization.
U.S. Agent Services
Designated U.S. Agent representation for foreign drug establishments.
GAP Analysis
Systematic identification of compliance gaps against current regulatory standards.
Audits & Control
Regulatory and quality audits with corrective action planning.
Reporting & Documentation
Technical writing, SOPs, and regulatory documentation management.
Manpower Planning / Management
Regulatory and quality staffing solutions for pharma operations.
Technology Transfer
Structured transfer of manufacturing processes and analytical methods.
Green Field Projects
Development of API and formulation manufacturing plants from the construction stage.
Unparalleled DMF Section Control
Our expertise in Drug Master File section control is unmatched. We navigate the most complex impurity challenges and regulatory requirements with precision and depth.
Starting Material Selection
Selection and redefinition of starting materials for synthetic APIs with full regulatory justification.
Specification Justification
Rigorous justification of specifications aligned with ICH guidelines and pharmacopoeial standards.
Organic Impurities
Expert handling of organic impurities not listed in monographs, with full characterization and qualification.
Nitrosamine Risk Management
Comprehensive nitrosamine risk assessment, control strategies, and regulatory response management.
Elemental Impurities
ICH Q3D-compliant elemental impurity risk assessments and control strategies for DMF filing.
Genotoxic Impurities
Assessment and control of genotoxic and mutagenic impurities per ICH M7 guidelines.
eCTD Conversion & Publishing
Full eCTD conversion and publishing services at both document level and submission/report level — compliant with FDA, EMA, and ICH standards.
ESG / CESP / CDER Direct
Complete portal setup for ESG, CESP, CDER Direct, and Next Gen. portals. DUNS and FEI Number registration, GDUFA self-identification, and annual establishment registration.
Structured Product Labeling
SPL preparation and NDC code assignment for any dosage form and application type, ensuring full compliance with FDA labeling requirements.
Let's Navigate
Compliance Together
Whether you're preparing a first DMF submission, managing a complex eCTD conversion, or building a manufacturing facility from the ground up — we have the expertise to guide you through every regulatory challenge.
Discuss Your Requirements
- DMF preparation and submission
- Company registration and regulatory liaison
- eCTD conversion and publishing
- Green field project development
- Impurity assessment and control strategy