Maxcure Laboratories | Regulatory Affairs & Dossier Services

At Maxcure Laboratories, we understand that regulatory compliance is the foundation of successful pharmaceutical business operations. Our dedicated Regulatory Affairs Division ensures that every product we develop, manufacture, and export meets the highest global standards while aligning with country-specific guidelines.

Our Regulatory Expertise

We provide end-to-end regulatory support for global markets, including CTD, eCTD, and ACTD submissions for all dosage forms and drug categories. Our services cover:

  • CTD & eCTD Submissions for regulatory authorities across USA, EU, Canada, Japan, Australia, and other regulated/semi-regulated markets.

  • ACTD Dossiers for ASEAN countries (Vietnam, Thailand, Malaysia, Singapore, etc.) with tailored documentation in four parts:

    • Part I – Administrative Information

    • Part II – Quality

    • Part III – Nonclinical Studies

    • Part IV – Clinical Studies

  • Non-ACTD / Country-Specific Dossiers – customized dossier preparation to match regional health authority requirements.

Comprehensive Dossier Services

Our team offers full dossier compilation, review, and submission support, including:

  • Preparation of New Drug Applications (NDA), Abbreviated NDA (ANDA), Investigational New Drug (IND), and Periodic Safety Update Reports (PSURs).

  • Writing, reviewing, and reformatting dossiers in CTD/ACTD/eCTD formats.

  • Preparation of Drug Master Files (DMF), Certificates of Suitability (CEP), and Summary of Product Characteristics (SmPC).

  • Stability studies, validation protocols, and COPP documentation to support product registration.

Packaging & Artwork Support

Our specialized design team assists in creating regulatory-compliant packaging and labeling, including:

  • Folding cartons, leaflets, blisters, labels, sachets, and tubes.

  • Multilingual packaging for EU, CIS, ASEAN, African, and LATAM markets.

  • Artwork development in line with global submission requirements.

GMP Documentation & Compliance

We also assist pharmaceutical companies with GMP documentation services, including:

  • SOPs for QA, QC, Production, R&D, and Safety.

  • Validation Master Plans, Site Master Files, and Process/Analytical Validation.

  • Annual Product Reviews & Regulatory Audit Support.

Why Maxcure Laboratories?

✔ Regulatory Expertise across 60+ countries
✔ Time-bound, compliant, and authentic documentation
✔ Customized solutions for start-ups and established companies
✔ Strong technical & scientific writing team

At Maxcure Laboratories, our goal is not just regulatory approval—it’s to ensure global accessibility of safe, effective, and affordable medicines.

📩 Contact us today to explore how we can support your regulatory and documentation needs worldwide.

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