Biological products are complex medicinal products and include a wide range of subcategories such as recombinant therapeutic proteins, vaccines, blood & plasma products,monoclonal antibodies, cellular & gene therapy products, vaccines etc. The Regulatory requirements for biological products are vast and vary based on the type of product. We understand complexities of the biologics industry. Our competence stretch over all facets and levels of Regulatory Affairs, from early phase & bioanalytical sciences through late phase and post approval.

• Preclinical & CMC Consulting
• Regulatory strategy/Regulatory insight reports for entry into new RoW countries.
• Setting up agency meetings and representing the sponsors to resolve scientific matters during the product registration.
• Biological product registration in all RoW markets (Asia, Africa, LATAM, GCC, & CIS).
• Country-specific Regulatory gap assessment for registration of intended biological product/ biosimilar product.
• Core dossier preparation in country-specific formats, necessary support for translation of dossier into the local language and Regulatory submissions management.
• FDA Meetings & Briefing Package Assistance
• Clinical Trial Applications
• Marketing Applications
• Medical Writing
• Product Lifecycle Management
• Submission Planning & Strategic Support
• eCTD Publishing & Submissions & SOP Development.
• Strategic Consulting & Intelligence
• US Agent
• Project Management Support
• Clinical Development Support
• Clinical Research Organization (CRO) Sourcing
• Analytical Development Support
• Bioassay Design and Validation
• Immunoassay
• Statistical Analysis and Specification setting
• Portfolio and Risk Management.
• Audit Readiness
• Protocol development
• Supplemental resources on your development team to execute and oversee programs
• Clinical pharmacology expertise and support for pharmacokinetic analyses
• Integrated market access, pricing, communications, and health economics experts, strategies and tactics to demonstrate the value of your product and support brand success around the globe.