API Sourcing, RLD Identification and Sourcing, Supply Chain Support
We deliver end-to-end API and supply chain intelligence to ensure secure, compliant, and uninterrupted sourcing. Our team conducts rigorous evaluations to qualify vendors, assess technical capabilities, and support global regulatory expectations. From DMF reviews to impurity sourcing, we streamline all upstream activities to strengthen product development foundations and mitigate procurement risks.
Key Capabilities:
- Strategic sourcing and qualification of APIs, intermediates, and nitrosamine-related materials
- Comprehensive API DMF review, technical gap analysis and compliance assessment
- Vendor identification, technical due diligence, and qualification audits
- Procurement support for impurities, intermediates, and reference standards
- End-to-end RLD identification, sourcing, and procurement support
Formulation Development & Technology Transfer Services
Our formulation experts provide robust scientific and technical support spanning development, optimization, scale-up, and technology transfer. We help organizations accelerate product readiness through data-driven formulation strategies, CMC compliance, and efficient lifecycle management.
Key Capabilities:
- Development and optimization of solid oral and injectable formulations
- Seamless technology transfer from R&D to pilot or commercial-scale manufacturing
- Process development, scale-up strategy, and validation planning
- CMC documentation and technical support for ANDA and MA submissions
- Regulatory deficiency responses, gap closure, and lifecycle management
- End-to-end dossier support for in-licensing and out-licensing opportunities
Clinical & Regulatory Services
We offer strategic, science-led clinical and regulatory services designed to streamline development timelines and enhance global submission success. From protocol development to CTD preparation, we ensure documentation is precise, compliant, and regulator-ready.
Key Capabilities:
- BA/BE study design and planning for various formulations such as solid oral, inhalation, topical creams as per regulatory requirements
- Protocol writing, CSR drafting, and full-suite regulatory documentation
- Dossier preparation, formatting, and submission support (CTD/eCTD)
- End-to-end consulting for EMA, US FDA, Health Canada, MHRA, and emerging markets
Audit, Monitoring & Technical Operations Support
We strengthen operational readiness through comprehensive audit preparation, technical oversight, and facility support. Our experienced team provides end-to-end monitoring, installation advisory, and compliance-oriented solutions across manufacturing, CRO, and laboratory environments.
Key Capabilities:
- GMP/GCP/GLP audits, site qualification audit, BA/BE study onsite or remote monitoring
- CRO setup, QMS setup, GCP/GLP trainings
- Cold-chain logistics planning, qualification, and oversight
- Advisory support for installation of solid oral and injectable manufacturing lines
- Equipment identification, URS preparation, vendor coordination, and installation support
Advanced Scientific Services
Our advanced scientific capabilities help clients solve complex development challenges through modelling, scientific interpretation, and high-quality documentation. We combine analytical problem-solving with regulatory insight to support strong scientific justification and submission outcomes.
Key Capabilities:
- PBPK modelling and biowaiver strategy development—including for complex generics
- Preparation of scientific reports, publications, and medical writing deliverables
- Data interpretation, justification writing, and technical position development