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Ziva DRA

Regulatory Affairs & Market Access in Bangladesh
Integrated Regulatory & Business Services

Expertise Across the Full Market Access Lifecycle

Ziva DRA provides regulatory affairs, clinical and research, global market access, and business compliance services for healthcare and life-science companies operating in Bangladesh.

Service Portfolio

Four specialist practice areas coordinated around regulatory, research and operational requirements.

Regulatory Affairs Registration, dossiers and lifecycle compliance
Clinical & Research Clinical, BA/BE and bioanalytical support
Global Market Access International regulatory and dossier support
Business Compliance Corporate, tax, trade and licensing support
Regulatory Affairs Healthcare product registration and compliance.
Clinical & Research Research and evidence-generation support.
Global Market Access International regulatory and quality support.
Business Compliance Corporate formation, licensing and compliance.
01 / Regulatory Affairs

Product Registration & Regulatory Compliance

Regulatory support for healthcare and life-science products, from pathway assessment and documentation through submission, approval and continuing compliance.

Regulatory Affairs

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Medical Device Registration

Regulatory pathway, documentation and registration support for medical devices.

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IVD Registration

Registration and regulatory support for in-vitro diagnostic products.

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Medicine Registration

Regulatory support for pharmaceutical registration and product approval.

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Cosmetics Registration

Registration and compliance support for cosmetics and related products.

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API Source Validation

Support for regulatory assessment and approval of API source requirements.

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Pharmacovigilance

Safety and lifecycle compliance support for pharmaceutical products.

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02 / Clinical & Research

Clinical Development & Research Support

Services supporting clinical research, bioavailability/bioequivalence requirements and bioanalytical development programs.

Clinical & Research

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Clinical Trial Support

Regulatory and project support for clinical research activities.

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BA/BE Studies

Support for bioavailability and bioequivalence study requirements.

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Bioanalytics

Bioanalytical support for research and development activities.

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03 / Global Market Access

Global Regulatory & Quality Support

International regulatory, dossier and GMP consulting services supporting companies across multiple markets.

Global Market Access

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Global Regulatory Affairs

Regulatory strategy and support for international product markets.

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Dossier Preparation

Regulatory dossier preparation, compilation and review support.

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GMP Consulting

GMP readiness, quality systems and compliance consulting.

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04 / Business Compliance

Corporate, Licensing & Operational Compliance

Business establishment and compliance services for companies operating in Bangladesh.

Business Compliance

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Company Formation

Corporate formation and registration support in Bangladesh.

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Trade License

Trade license application and operational compliance support.

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Tax & VAT

Tax and VAT registration and business compliance support.

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Import Registration Certificate

IRC application support for businesses engaged in import operations.

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Export Registration Certificate

ERC registration support for export-oriented businesses.

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Trademark Registration

Trademark registration support for business and brand protection.

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Integrated Project Delivery Regulatory, research, quality and business requirements coordinated around a single market-entry objective.
How We Deliver

Specialist Expertise with One Coordinated Approach

Complex market-entry projects often involve more than one regulatory or business requirement. Ziva DRA helps coordinate related workstreams within a structured engagement model.

Requirement Assessment Identify the regulatory, research and compliance scope.
Documentation Management Coordinate dossiers, applications and supporting records.
Submission & Follow-up Support relevant regulatory and business processes.
Ongoing Support Help manage renewals and continuing compliance requirements.
Engagement Process

From Requirement to Delivery

A structured workflow designed for regulatory, research and compliance engagements.

Consultation

Understand your product, company and objective.

Assessment

Identify relevant requirements and service scope.

Preparation

Prepare documents, applications and supporting records.

Execution

Coordinate submissions, studies or compliance activities.

Ongoing Support

Manage follow-up, renewals and continuing requirements.

Need Regulatory, Research or Compliance Support?

Tell us about your product or business requirement. Ziva DRA can help identify the relevant service pathway for your Bangladesh market objective.

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