Comprehensive Life Sciences Services
End-to-end solutions for pharmaceutical, biotech, and medical device companies worldwide.
Regulatory Excellence & Strategic Guidance
FDA, EMA & US-EU Submission Support
Navigating the complex regulatory landscape is critical for market success. We provide comprehensive regulatory support for drug (NDA, ANDA), device (510k, PMA), and biologic (BLA) submissions across global markets, with specialized expertise in US and EU requirements.
Our team of regulatory experts ensures that your submissions are robust, compliant, and positioned for a smooth review process. We offer strategic guidance on regulatory pathways and agency interactions.
- Dossier/ANDA/DMF/ASMF preparation and filing
- GMP audits, response and CAPA implementation
- eCTD/NeeS/paper submissions and lifecycle management
- Readiness for regulatory inspections
Access our free readiness checklist and compliance resources for a successful inspection.
Global Supply Chain & Logistics Mastery
International Shipping
Reliable and compliant shipping of pharmaceutical products worldwide, including cold-chain and hazardous materials logistics.
Cost Chain Management
Optimizing supply chain costs through strategic sourcing, inventory management, and logistics planning without compromising quality.
Distribution Network
Extensive global network for efficient distribution, ensuring timely delivery to diverse markets and overcoming regional challenges.
We also offer specialized services for clinical trial supply management, including sourcing, packaging, labeling, and distribution of investigational medicinal products (IMPs).
Strategic Sourcing & Procurement Excellence
Custom Procurement Solutions
Market Intelligence
Supplier Qualification
Contract Negotiation
Clinical Trials & Technology Transfer
Clinical Support
- Comprehensive services for clinical trials including IMP sourcing, packaging, and labeling.
- Full regulatory support for clinical trial applications.
Licensing & Technology Transfer
Facilitating in-licensing of innovative products and technologies for market expansion.
End-to-end management of technology transfer from lab to commercial scale, ensuring seamless transition.
- •IP analysis, due-diligence, and regulatory pathway assessment.
- •Process validation, optimization, and scale-up.
- •Training, documentation, and post-transfer support.
Medical Marketing & Market Access
Our integrated approach ensures your product reaches the right audience with a compelling value story, driving successful market adoption and commercial success.
Medical Affairs Support
Comprehensive medical affairs strategy, KOL mapping and engagement, advisory board meetings, and IIS/CME/Grant management programs.
Scientific Communication
Publication planning, medical writing, conference support, and development of high-impact scientific communication materials.
Market Access Strategies
Value proposition development, pricing and reimbursement strategy, HTA submissions, and real-world evidence generation.
Our team helps you navigate market access complexities and build a strong scientific narrative to engage stakeholders effectively. From pre-launch to post-launch, we provide the strategic support you need to maximize your product's impact.