Comprehensive Regulatory Solutions Under One Roof
Eleven integrated service areas covering every dimension of pharmaceutical regulatory compliance — from Quality Assurance and DMF preparation to Green Field facility development.
Quality Assurance / Control
Comprehensive QA/QC systems aligned with cGMP and GxP standards.
Scope of Services
- Quality Management System (QMS) design and implementation
- SOP development and review
- Batch record review and deviation management
- Change control and CAPA management
- Vendor qualification and audit programs
- GMP compliance gap assessments
Regulatory Affairs / Compliance
End-to-end regulatory strategy and dossier management for global submissions.
Scope of Services
- Dossier compilation in CTD, ACTD, NeeS, and eCTD formats
- DMF, CEP, ASMF, IND, NDA, ANDA, BLA, MAA, and 505(b)(2) submissions
- Paper submissions and old product dossier conversions
- Structural Product Labeling (SPL) for any dosage form
- Regulatory strategy and submission planning
- Post-approval change management
Product Development
API and formulation development support from concept to commercialization.
Scope of Services
- API synthesis route development and optimization
- Formulation development for all dosage forms
- Analytical method development and validation
- Stability study design and management
- Scale-up and process optimization
- Pre-formulation studies and compatibility testing
U.S. Agent Services
Designated U.S. Agent representation for foreign drug establishments.
Scope of Services
- Designated U.S. Agent for FDA-regulated facilities
- FDA correspondence and communication management
- Annual establishment registration facilitation
- GDUFA self-identification support
- FEI Number registration and maintenance
- Import alert and detention response support
GAP Analysis
Systematic identification of compliance gaps against current regulatory standards.
Scope of Services
- Current state assessment against ICH, FDA, and EMA guidelines
- Regulatory readiness evaluation for new markets
- Pre-inspection readiness assessments
- Remediation roadmap development
- Risk-based prioritization of compliance gaps
- Benchmarking against industry best practices
Audits & Control
Regulatory and quality audits with corrective action planning.
Scope of Services
- GMP facility audits (domestic and international)
- Supplier and vendor qualification audits
- Pre-approval inspection (PAI) readiness
- Mock FDA/EMA inspection preparation
- Audit report preparation and CAPA follow-up
- Third-party contract manufacturer audits
Reporting & Documentation
Technical writing, SOPs, and regulatory documentation management.
Scope of Services
- Technical report writing (stability, validation, analytical)
- SOP and work instruction authoring
- Regulatory submission document preparation
- Document management system design
- Labeling and package insert development
- Annual product review (APR/PQR) preparation
Manpower Planning / Management
Regulatory and quality staffing solutions for pharma operations.
Scope of Services
- Regulatory affairs staffing and resourcing
- Quality assurance personnel placement
- Training program design and delivery
- Competency assessment frameworks
- Interim regulatory leadership
- Organizational structure consulting
Technology Transfer
Structured transfer of manufacturing processes and analytical methods.
Scope of Services
- API and formulation process transfer protocols
- Analytical method transfer and validation
- Site-to-site transfer documentation
- Scale-up and tech transfer risk assessment
- Regulatory filing updates post-transfer
- Knowledge management and training support
Drug Master File, ACTD, CTD & eCTD
Complete DMF lifecycle management and eCTD conversion and publishing services.
Scope of Services
- Type II (API) and Type IV (Excipient) DMF preparation
- CEP (Certificate of Suitability) and ASMF applications
- eCTD conversion at document and submission level
- eCTD publishing and validation
- ESG, CESP, CDER Direct, and Next Gen. portal setup
- DUNS, FEI, GDUFA, and NDC code registration
Green Field Projects
Development of API and formulation manufacturing plants from the construction stage.
Scope of Services
- Site selection and feasibility assessment
- Facility design and layout consulting (GMP-compliant)
- Equipment qualification (IQ/OQ/PQ)
- Utility and HVAC system qualification
- Regulatory filing for new manufacturing sites
- Commissioning and start-up support
Ready to Streamline Your Compliance?
Contact us to discuss your specific regulatory requirements. We handle everything from initial strategy to final submission — saving you time and resources.