SolReg Partners

J.W. Speaker Corporation

J.W. Speaker designs and manufactures innovative, high-performance LED lighting technology for automotive, powersports, transport, and industrial products. They specialize in custom LED solutions for OEMs and offer a vast network of partners.

J.W. Speaker is a leader in developing and manufacturing innovative, high-performance LED lighting technology for a wide range of applications including automotive, powersports, transport, and industrial products. They specialize in partnering with Original Equipment Manufacturers (OEMs) to provide custom LED lighting solutions that deliver enhanced performance and stunning aesthetics. With a commitment to quality and innovation, J.W. Speaker designs, manufactures, and assembles its products in Germantown, Wisconsin. They are certified to rigorous automotive standards including ISO 9001, ISO 14001, ISO 26262, and IATF 16949, ensuring their products meet the highest industry requirements. The company offers a comprehensive catalog of LED lighting products, including headlights, light bars, fog lights, trail lights, and more, catering to various vehicle types and categories. They also provide extensive resources for customers, including FAQs, troubleshooting guides, and installation instructions, to ensure optimal product performance and customer satisfaction.

About

**Who they are**
SolReg Partners is a Brazilian entity focused on providing regulatory support for companies seeking to market products in Brazil. They specialize in acting as the Local Representative for foreign manufacturers.

**Expertise & scope**
* Navigating ANVISA regulations for product registration and compliance.
* Serving as the official Local Representative for foreign manufacturers.
* Facilitating communication and submissions with ANVISA.
* Ensuring adherence to Brazilian regulatory requirements.

**Reputation / proof points**
* Coverage: Brazil (BR)

Additional information

Engaging SolReg Partners as your Local Representative in Brazil is crucial for navigating the complex regulatory landscape overseen by ANVISA. Their expertise ensures that foreign manufacturers can effectively manage product registrations, ongoing compliance, and communication with regulatory authorities. This local presence is often a mandatory requirement for market access, streamlining the process and mitigating potential delays or rejections. Buyers should be prepared to provide comprehensive product documentation and technical information to facilitate the registration process.

Key Highlights

  • Local representative services for Brazil's ANVISA Source
  • Market access and lifecycle support for foreign manufacturers Source
  • Operational liaison for ANVISA regulatory communications Source
  • Coordination of documentation for ANVISA submissions and updates Source

Certifications & Trust Signals

  • Structured onboarding and pathway confirmation for Cadastro and Registro Source
  • Support for Portuguese-language readiness of technical documentation and labels Source
  • Post-market process coordination, including incident escalation and complaint handling Source

Buyer Snapshot

Best for
  • Foreign manufacturers seeking ANVISA representation
  • Companies needing local regulatory expertise in Brazil
How engagement typically works
  • Acting as the official Local Representative
  • Facilitating regulatory submissions and communication
Typical deliverables
  • ANVISA registration support
  • Local Representative services
  • Regulatory compliance guidance for Brazil
Good to know
  • Best when local representation is a mandatory requirement for market entry
HQ: Germantown, US
Languages: Portuguese, English
Timezones: America/Sao_Paulo
Status: listed

Services & Capabilities

Brazil ANVISA Local Representative Services

Jurisdictions: BR
Countries: BR
Industries: Medical devices, IVD, Life sciences
Portfolio: 26-100
Onboarding time: 10–45 days
Pricing model: Onboarding + annual retainer
Starting from: USD 9,000
Included services: Local representative mandate setup, ANVISA liaison and communications routing, Cadastro/Registro pathway support, Portuguese documentation enablement (scope-dependent), Post-market coordination support (scope-dependent)
Supports Cadastro: No
Supports Registro: No
Portuguese Support: No
Local License Capability: No
Translation Support Ptbr: No
Post Market Support: No
Product Categories Supported: Headlights, Light Bars, Fog Lights, Trail Lights, Stop, Tail and Backup Lights, Turn Signal Lights, Interior Lights, Work Lights, Marine Navigation, Emergency Lights, AC/DC Converters and Controls, License Plate Lights

Additional br_local_rep Details

Included Services Detailed
Local representative onboarding and mandate setup (seed scope), ANVISA liaison and communications routing (seed scope), Submission planning for Cadastro/Registro pathways (seed scope), Portuguese documentation readiness enablement (seed scope), Post-market workflow coordination (complaints/vigilance escalation) (seed scope)
Excluded Services
Manufacturing or supply chain execution, Acting as commercial distributor by default, Legal representation in disputes or litigation
Onboarding Steps
Requires company information, product details, and relevant technical documentation for ANVISA submissions.
ANVISA Registration Details
Supports both Cadastro and Registro pathways (seed summary). Typical scope includes onboarding, documentation planning, submission coordination, and change management support (seed summary).
Local Entity Details
Local operations coordinated from Brasília with Brazil-based contact point for regulator communications (seed summary).
Product Categories Supported
Medical Devices, IVDs, Cosmetics, Food Products, Health Products, Pesticides, Sanitaries
Supports Cadastro
Yes
Supports Registro
Yes
Portuguese Support
Yes
Local License Capability
Yes
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