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Global clients
35
Years Of
Experience
About
Tactus Lifesciences
At Tactus Lifesciences, our foundation is built upon the collective expertise and vision of seasoned pharmaceutical industry experts. Our operations have expanded to span over 27 countries across the globe, thanks to our trusted partners.
From our very inception, Tactus Lifesciences has been actively involved in sourcing Reference Listed Drugs (RLD), branded biologics, specialty medicines, and finished dosage formulations (FDF). With a unique blend of experience, strategic relationships, innovative approaches, and profound expertise in pharmaceutical regulatory affairs, we deliver unparalleled regulatory services to our clients with expert support throughout your product lifecycle from development to MAA renewal, globally.
We facilitate the in-licensing and out-licensing of pharmaceutical products to expand market reach and foster collaborations.
At Tactus Lifesciences, collaboration is at the heart of what we do. We are not just a service provider; we are your strategic partner in pharmaceutical success. Join us as we pave the way for innovation, collaboration, and excellence in the dynamic world of life sciences.
What We Offer
Regulatory Services
Enhance product commercialization globally with our Regulatory Strategy team, adept at ensuring regulatory compliance and market flexibility through agency collaborations.
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RLDs/Comparator Sourcing
Tactus Group delivers top-tier pharmaceuticals worldwide, specializing in branded, generic, specialty, controlled substance, and biosimilar products with extended shelf life.
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In-Out Licensing
Tactus Group facilitates seamless in- and out-licensing opportunities for pharmaceutical products, ensuring strategic partnerships and expansion of product portfolios.
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Our Solutions
Comprehensive Regulatory
Comprehensive Regulatory
Solutions
Regulatory due diligence & gap Analysis
Our Regulatory Due Diligence & Gap Analysis service ensures seamless compliance throughout the product life cycle, empowering organizations to navigate regulatory landscapes confidently with:
- Compliance Audits
- Gap Identification
- Strategic recommendations to mitigate risks
Regulatory consulting and strategy services
From global regulatory support to expert query responses, our streamlined services cover all aspects of pharmaceutical compliance and strategy.
- New product development and filing strategy (Pre & Post Approval)
- Regulatory compliance consulting to address agency queries
- Regulatory submission strategy for drug expansion in another market
Dossier Submission for the Global market
Our Dossier Submission for the Global Market service ensures streamlined regulatory compliance worldwide, offering meticulously crafted templates and expert dossier compilation tailored to meet diverse regulatory requirements.
- Dossier Compilation and submission to global health agencies
- Submission of MRP/DCP/IRP for drug registration
- Submissions of MAAS/ NDAS/ANDAS/DMF
Life Cycle Management
Our Life Cycle Management service offers expert solutions to navigate regulatory complexities and maintain product quality throughout its lifecycle.
- Expertise in Product Lifecycle Management based on global Health Authority requirements.
- Filing of variations/supplement
- Filing of Annual reports
Bioequivalence & Biowaiver
Our Bioequivalence & Biowaiver services provide tailored solutions, including bioequivalence and clinical strategies, as well as biowaiver support with justification documents, empowering successful drug development and approval.
- Bioequivalence and clinical strategies
- Biowaiver support and providing justification documents.
Labeling And Artwork Services
Our Labeling and Artwork Services combine meticulous crafting designs with unparalleled market intelligence and deep product knowledge, ensuring compliance and quality throughout your product's lifecycle.
- Design of artwork elements various packaging materials
- Patient information leaflets design
- Manage end-to-end labeling changes per relevant global regulations.
Standalone Services
At Tactus Lifesciences, we offer a comprehensive suite of standalone services, including EU and USA Local Agent and Office Support, Independent Module Preparation, Medical Writing, RTR Support, Translation Service, and Clinical Trial Supply., meticulously tailored to efficiently address specific regulatory needs.
- EU and USA Local Agent and Office Support
- Batch Release, Batch Testing, and MIA
- Independent Module Preparation (Clinical & Non-Clinical)
- Medical Writing/RTR Support
Why Partner With Us?
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Global presence
Our Clients
