Regulatory Services

Tactus Lifesciences provides specialized regulatory affairs services for pharmaceuticals, supporting global submissions, approvals, and compliance with EU, US FDA,MHRA, Health Canada, TGA and other regulatory agencies.

At Tactus Lifesciences We Provide End-to-end Pharmaceutical Regulatory Affairs Services

At Tactus Lifesciences, we recognize the pivotal role that Regulatory Affairs services play in the journey of drug development and commercialization. In today's dynamic and ever-evolving global health landscape, compliance is not just a checkbox; it's an imperative for success. With the complexities inherent in regulatory processes, having a dedicated team of experts to navigate through the details is essential.

Our Approach

At Tactus Lifesciences, we understand the nuances of regulatory affairs, and we're here to bridge the gap between your organization and Global Health Authorities. Our seasoned team of regulatory experts meticulously track and interpret the key regulations pertinent to your product, ensuring compliance at every step of the journey.

What Sets Us Apart:

Global Reach

Tactus Lifesciences serves as your gateway to key Regulatory authorities worldwide, facilitating smooth interactions and compliance on a global scale.

Tailored Solutions

We understand that every project is unique, which is why we offer customized Regulatory Affairs services to suit your specific goals and objectives.

Strategic Support

From product development to commercialization, we provide strategic guidance to maximize market value and ensure successful launches.

Compliance Assurance

Our stringent adherence to regulatory standards guarantees that your products meet all necessary requirements for market approval.

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.

eCTD Dossier Preparation & Global Submissions

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

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.

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

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

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.

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.

Office Address

Phone Number

Email Address