Our Services
Dossiers (CTD, e-CTD, ANDA, ANVISA)
We prepare detailed regulatory dossiers tailored to country-specific formats such as CTD, e-CTD, ANDA, and ANVISA, ensuring compliance with client requirements. Our services enable seamless product registration and approvals in multiple global markets.
- Country-specific dossier compilation
- Regulatory submission guidance
- Continuous updates for compliance
DMFs (CTD, e-CTD) Open & Closed Part
We manage Drug Master Files (DMFs) according to regional and global standards, covering both open and closed parts. Our expertise ensures smooth submission and maintenance across varied regulatory requirements.
- Preparation of technical and quality documents
- Support for regulatory audits
- Timely submission and updates
Technology Transfers (API & Formulations)
Our team facilitates efficient technology transfer for APIs and formulations through paper technology and product development support. We ensure smooth handover and replicable processes to enhance manufacturing scalability.
- Comprehensive documentation and training
- Process optimization and troubleshooting
- Coordination between development and manufacturing teams
Pharmacovigilance (PV)
We provide end-to-end pharmacovigilance services to monitor drug safety and ensure regulatory compliance. Our PV process encompasses adverse event reporting, signal detection, and risk management.
- Comprehensive documentation and training
- Process optimization and troubleshooting
- Coordination between development and manufacturing teams
Intellectual Properties (IP)
Our IP services protect pharmaceutical innovations through patent filing, trademark registration, and strategic advice. We help clients safeguard their R&D investments in local and international markets.
- Patent drafting and filing support
- Trademark and copyright management
- IP portfolio management and strategy
AMV, BMR, BPR, and BE Reports
We prepare essential analytical method validation (AMV), batch manufacturing records (BMR), batch packaging records (BPR), and bioequivalence (BE) study reports adhering to country-specific requirements to support regulatory submissions.
- Documentation per regulatory guidelines
- Quality control compliance verification
- Support for clinical and regulatory audits
Product Development for APIs & Formulations
We have dedicated, specialized teams focused on the development of APIs and pharmaceutical formulations to accelerate innovation and ensure high-quality product development.
- Research and process design
- Formulation optimization
- Regulatory support and documentation
Product Documentation & Regulatory Services
We deliver comprehensive product-related documentation including manufacturing processes, training manuals, troubleshooting guides, and regulatory filings, ensuring operational consistency and regulatory adherence.
- Process and training documentation
- Troubleshooting and quality control guides
- Regulatory dossiers and compliance support