Preloader

Office Address

704,705 Swati Trinity, Applewoods Township, Shantipura, Ahmedabad, Gujarat 380054, 380058.

Phone Number

+91 9510473492

Email Address

Info@tactuslifesciences.com

MA Holding (EU/UK/US), BR-BT and Warehousing Support

Why It Matters

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 without interruptions, while avoiding the need to set up local subsidiaries. This is essential for companies seeking global expansion and uninterrupted market access.

Our Expertise

At Tactus Lifesciences, we act as your official MA holder with extensive experience across EU, UK, and US markets. Our regulatory experts manage the entire lifecycle of your product’s authorization — from initial submission to renewals, variations, and post-approval compliance. We liaise directly with authorities, handle queries, and ensure all regulatory obligations are met, giving you peace of mind and faster market access.

Regulatory Services

Our Services Include

  • Acting as the official MA holder in EU, UK, and US markets
  • Management of regulatory submissions, renewals, and variations
  • Ensuring full regulatory compliance with local authorities
  • Supporting product launches, market continuity, and lifecycle management
  • Guidance for companies entering new markets without establishing a local entity

Our Global Solutions

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.

READ MORE
eCTD Dossier Preparation & Global Submissions

The electronic Common Technical Document (eCTD) is the standard format for submitting regulatory dossiers across global agencies.

READ MORE
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.

READ MORE
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

READ MORE
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

READ MORE
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.

READ MORE
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.

READ MORE

Our Clients