What is Global Market Access (GMA)?

Global market access is a company’s ability to enter a foreign market by selling its goods and services in another country.

What is Global regulatory compliance requirement (GRCR)?

  • Global compliance means ensuring that product comply with all the local or international specifications, standards or laws and rules in every country in which you operate.
  • Regulatory compliance describes the goal that organizations want to attain in their efforts to ensure that they are aware of and take steps to comply with applicable laws, policies and regulations.
  • Compliance with regulations varies by industry and place as well.

Why is Regulatory Compliance important?

  • Regulatory compliance is important to protect consumer and public from harm.
  • For consumers or buyers, to them from the harmful consequences of actions carried out by company.
  • For business to product their brands and reputations.
  • Product compliance should meet the essential requirements in the form of directives, regulation and harmonized standards.

Here’s How a Consultant Can Help You!!!

  1. Confirm applicable directives or regulations with specific product standards.
  2. Confirm mandatory or voluntary standards/regulations in your market, country or state.
  3. Identifying particular tests required for your device.
  4. Assisting in preparation of different technical document for your product.
  5. Develop a new product design concept.
  6. Technical Documentation reviews under the Directives and Regulation.
  7. Create label files and technical documentations.
  8. Confirm applicable labelling requirements.
  9. Confirm applicable documentation or certification.
  10. Confirm/ prepare critical component lists with compliance requirements according to country specifications.
  11. Failure analysis.
  12. Design review and compliance assistance.
  13. R&D support etc.

This is necessary documents need to provide before requesting a quotation.

  1. Technical details of the product with photos.
  2. Product type, product category and product class etc.
  3. Manufacturing country and consumer country.
  4. Technical docs (If any)
  5. Product label (If any)