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To launch a medical device, compliance with each country’s regulations is essential. Let us be your trusted partner in bringing your devices to the global market. Contact us to learn how we can support you at every step.

13485:2016
17100:2015

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Home
About
Services
Product Registration Ensure your medical product meets all regulatory requirements before market launch.

Authorized Representative Designate a legal representative to handle compliance and communication with authorities.

Are you a Startup? Special support and guidance tailored for new and emerging medical ventures.

Product Classification Determine the correct regulatory category for your medical device or software.

Technical Documentation Prepare all necessary documentation to demonstrate safety and performance.

Quality Assurance Maintain consistent quality and compliance across all stages of production.

Post Market & Vigilance Monitor and report product performance and safety after market release.

Software as a Medical Device Guidance for regulatory compliance specific to medical software applications.

ISO 13485 and QMS Support Implement and maintain a compliant Quality Management System to meet international medical device standards.

Medical Devices and IVDs Learn More

Product Registration And Notification Ensure your pharmaceutical product meets all regulatory requirements before market launch.

Representation Services Cosmetic companies based outside of the jurisdiction in which they wish to promote their products may be required by law

Claims Assistance Claims pertaining to a product are employed to demonstrate that a product or group of products is certified

Product Testing The scientific method of assessing the quality, safety, and efficacy of cosmetic goods is known as cosmetic product testing

Label Review Since the goal of cosmetic product labelling is to provide consumers with correct information about a product

Good Manufacturing Practices Good Manufacturing Practices The processes put in place by a company to guarantee

Cosmetic Learn More

Product Registration Ensure your pharmaceutical product meets all regulatory requirements before market launch.

Marketing Authorization Holder Appoint a responsible entity to hold and maintain regulatory approval for your product.

Dossier Filing Prepare and submit comprehensive documentation to regulatory authorities for product approval.

Product Testing Conduct required laboratory and safety tests to ensure product quality and compliance.

GMP Compliance Audit Conduct required laboratory and safety tests to ensure product quality and compliance.

Pharmacovigilance Monitor, assess, and report adverse effects to ensure ongoing safety of pharmaceutical products.

Pharmaceuticals Learn More

Representation Services Appoint a legal representative to manage regulatory compliance and communication with authorities.

Custom Clearance Handle customs documentation and procedures to ensure smooth and legal product importation.

Importer Services Facilitate the import of medical, cosmetic, or pharmaceutical products while ensuring regulatory compliance.

Authorized Representative Learn More

Localization Adapt your content and products to meet local language, cultural, and regulatory requirements.

Proofreading Review translated content for accuracy, grammar, and compliance with industry standards.

Translation Convert documents and materials accurately between languages while maintaining meaning and context.

Global Translations Service Learn More

Food Supplement Food supplements, also known as dietary supplements, are products taken orally that contain dietary ingredients intended to supplement one’s diet.

Food Supplement Learn More
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