STRATEGIC SERVICES
Plan your Strategy,
Strategize your plan
Amarant is the reliable partner you need to navigate complex global regulatory requirements. With our expertise, experience, and access to official guidelines, we deliver regulatory intelligence, strategic submissions, and customized product development strategies. You can rely on us for regulatory excellence and to elevate the outcomes of your pharmaceutical ventures.
Services We Offer
- Due-diligence for mergers, acquisitions and investments
- Contract Manufacturing facilities for various dosage forms
- Regulatory intelligence and strategy
- Contract Research Organisations for product and analytical development
- Scientific advice and FDA pre-submission meetings
- Global product development & global dossier management strategy
- NDA submissions: 505(b)(1) & 505(b)(2), Article 8(3)
- Quality system inspections: Strategy & inspection readiness
- Regulatory pathways across various geographies
- In-country representation and local services
- Marketing authorization applications
- Clinical & non-clinical study strategy
- MA In-licensing & out-licensing
- Quality strategy
- Training & its implementation strategy
- GxP requirements