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Global clients
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Experience
Years Of
About Us
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.
At Tactus Lifesciences, collaboration is at the heart of what we do. Join us as we pave the way for innovation, collaboration, and excellence in the dynamic world of life sciences.
Our Global Solutions
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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GMP compliance
Empowering You with Quality-Centric GMP Solutions At Tactus, GMP compliance isn't just a checkbox—it's a strategic advantage. We support pharma companies
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Pharmacovigilance
At Tactus Lifesciences, patient safety is our highest priority. Our comprehensive Pharmacovigilance (PV) solutions help pharmaceutical and biotech companies meet global regulatory
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Our Solutions
Comprehensive Regulatory
Comprehensive Regulatory
Solutions
Regulatory Strategy, Gap Analysis & Market Access Support
A strong regulatory strategy ensures your product development aligns with global requirements from day one. Gap analysis helps identify missing or weak areas early, saving time, cost, and reducing approval risks.
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Product Selection & Development Strategy
A strong product selection and development strategy ensures that your product is not only technically feasible, but also meets unmet market needs, regulatory requirements, and commercial viability.
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eCTD Dossier Preparation & Global Submissions
The electronic Common Technical Document (eCTD) is the standard format for submitting regulatory dossiers across global agencies.
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MA Holding (EU/UK/US)
Entering regulated markets like the EU, UK, and US requires a local Marketing Authorization (MA) holder to ensure compliance with complex regulations. Having a trusted MA holder allows your products to reach patients
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BE/Biowaiver Strategy & Clinical/Non-Clinical Modules
Bioequivalence (BE) studies and Biowaiver strategies are critical for generics and certain formulations to gain approval without full-scale clinical trials.
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QPPV / Pharmacovigilance Support
Pharmacovigilance is a regulatory obligation and a patient safety priority. Every Marketing Authorization Holder in the EU/UK must appoint a Qualified Person for Pharmacovigilance (QPPV) to oversee drug safety and risk management.
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Batch Release, Batch Testing & Warehousing Support
Ensuring the quality, safety, and timely availability of pharmaceutical and healthcare products is critical for regulatory compliance and patient safety. Proper batch testing, release procedures, and secure warehousing
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Global presence
Our Clients
