Biologics Regulatory Affairs Services — Global Support

From early-stage development to global market access, we help biologic products meet country-specific requirements with clarity and confidence.

Services We Offer

Biologics demand a different level of regulatory attention. From product characterization and comparability studies to post-market obligations, each step is bound by region-specific protocols. At Artixio, we work closely with companies developing monoclonal antibodies, vaccines, cell and gene therapies, or biosimilars, offering regulatory guidance shaped by science, precision, and country requirements.

Whether you’re preparing for FDA’s BLA pathway, EMA’s centralized procedure, or gaining acceptance in APAC, MENA, or LATAM regions, we help you align your product with the local authorities’ expectations — without slowing down your launch timelines.

Regulatory Affairs Lifecycle for Biologics

Pre-Development Advisory

Identify target market-specific requirements early

Product Characterization & Dossier Planning

Align studies, comparability, and data with regional needs

Regulatory Submissions

Prepare CTD, eCTD or other required formats

Authority Communication & Response Management

Handle queries, deficiencies, and updates promptly

Market Authorization & Launch Readiness

Support labeling, packaging, and final review steps

Post-Market Compliance & Reporting

Safety data, variations, renewals, and lifecycle tracking

Why Artixio for Biologics Regulatory Affairs

FAQs

1. What is the difference between drug and biologic regulation globally?

Biologics are regulated through separate agencies or divisions within regulatory bodies due to their complexity, variability, and production methods. Requirements around characterization, stability, and comparability are far more detailed than for small molecules.

2. Does Artixio support gene therapies and cell-based products too?

Yes, we handle a wide range of biologics, including ATMPs (Advanced Therapy Medicinal Products) such as gene therapies, CAR-T cells, and stem cell-based treatments.

3. How does Artixio assist with biosimilar registration across countries?

We help with data bridging, justification strategies, and comparability assessments for biosimilars across US, EU, and other major markets. We also support local requirements in emerging markets.

4. Can you manage regulatory submissions across multiple countries at once?

Yes, our team can coordinate simultaneous submissions through a unified strategy while aligning with each authority’s documentation preferences and timelines.

5. What kind of post-approval support do you offer for biologics?

We manage variations, renewals, safety reports, and manufacturing changes across different health authorities so your approvals remain active and compliant.