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Office Address

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

Phone Number

+91 9510473492

Email Address

Info@tactuslifesciences.com

Batch Release, Batch Testing & Warehousing Support

Why It Matters

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 minimize risks, maintain product integrity, and ensure uninterrupted market supply. Companies relying on external support benefit from expertise that bridges manufacturing, regulatory, and storage requirements seamlessly.

Our Expertise

Tactus Lifesciences offers comprehensive support across batch testing, batch release, and warehousing. Our experienced team ensures that every batch meets strict regulatory and quality standards, from rigorous testing to final release. We also provide GDP-compliant warehousing, including temperature-controlled storage and inventory management, ensuring your products remain safe, compliant, and market-ready.

Regulatory Services

Our Services Include

  • Batch Testing: Physical, chemical, and microbiological testing to verify product quality and compliance
  • Batch Release: Certification of batches in line with EU, UK, and US regulatory standards, including documentation review and coordination with manufacturing sites
  • Warehousing Support: Secure and temperature-controlled storage, inventory management, and assistance with distribution while adhering to Good Distribution Practices (GDP)
  • Support for timely product availability and uninterrupted market supply
  • Ensuring regulatory compliance and product integrity throughout the lifecycle

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.

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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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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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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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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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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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Our Clients