Services overview
Comprehensive CTD & Product Dossier Solutions for Global Registrations
End-to-End CTD Preparation and Regulatory Documentation Expertise
CTDs (Product Dossiers) are an essential component of any registration application for Marketing Authorization. A dossier in CTD format, ACTD format, or a local country-specific format is submitted to the Food & Drug Authority, Ministry of Health, or equivalent regulatory bodies, along with the required technical documents and legal manufacturing approvals.
Onco Indian International provides comprehensive support in preparing complete technical documents for product registration in multiple countries worldwide. We can compile and author the entire dossier or specific modules as per your requirements. Additionally, we assist companies in establishing robust document management and technical writing systems by providing draft templates and expert guidance needed to prepare CTDs.
Your Trusted Partner in Global Pharmaceutical Contract Manufacturing
The Contract Research and Manufacturing Services (CRAMS) segment is gaining global traction, with India witnessing remarkable growth in this space over recent years. Leveraging its strong growth potential, core competencies, and favorable regulatory environment, India is positioned to capture a substantial share of the global outsourcing market. Increasingly, international companies are offshoring their R&D and manufacturing operations to India, setting up cost-efficient facilities, and integrating India into the pharmaceutical industry’s global drug discovery and manufacturing value chain. This growth is further supported by advancements in intellectual property infrastructure, enabling India to strengthen its competitive edge.
In today’s competitive environment, businesses excel by focusing on their core strengths and outsourcing other functions. Contract manufacturing aligns perfectly with this strategy—offering reduced costs, enhanced flexibility, access to specialized expertise, and lower capital investment compared to in-house production. However, achieving optimal results demands skillful management of complex partnerships, requiring well-structured strategies and transparent collaboration.
Onco Indian International is a leading pharmaceutical contract manufacturing company, producing a wide range of high-quality products including tablets, capsules, injection vials, ampoules, creams, drops, dry syrup suspensions, and bulk drugs.
Unique Service Combinations Lead to Faster, Better Results
net synergies realized above the initial target in the first year.