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  Regulatory  

Sky International is a global company exclusively serving the respiratory medical device industry. We have expert resources located worldwide providing local expertise to expedite the product registration processes. Sky International’s regulatory services include regulatory strategy consulting, clinical trial management, product testing/compliance certificates, product registration applications, and in-country representation services.

Medical product registration in many emerging markets is a country specific, complex process, with each country maintaining its own unique product registration requirements.  The local registrations can be obtained in as quickly as 3 months, or can be extensive, lasting as long as 18 months and costing thousands of dollars.

Sky International has worked with numerous local Health Services and Ministries of Health to overcome government barriers that restrained access to affordable healthcare.  The company has also led numerous projects on local manufacturing initiatives to bring benefits from tax incentives, lower importation duties and barriers, and gain access to government tenders.

  Sky International Difference  

Sky International can process and hold product registration in the manufacturer’s name.  This arrangement allows Sky International the flexibility to add and subtract distributors, without having to re-register products, allowing continuous sales and local product availability. Selecting a local distributor to act as an agent and process product registrations in the manufacturers’ name  is a common solution; but it gives the distributor full control of your sales and reputation.

Country specific regulatory approvals are a time consuming and expensive process. Sky International has processed numerous product registrations and has both the resources and know-how to obtain a quick regulatory approval. 

  Beyond Regulatory Applications  
  Sky International will not just provide you with a regulatory approval, but will present regulatory options that can maximize your investment in the short term, but also provide you with the flexibility required as your company grows and your needs change.
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