Healthcare International Partners
Healthcare International Partners (HIP), established in 2009, is a leading partner in strategic growth for medical device and healthcare companies, providing integrated services including regulatory and commercialization support to expand into Latin America, the Caribbean, and select US markets. Their mission is to expedite product commercialization and help clients increase market share through strategic regulatory and commercialization services, with a vision to partner with exceptional manufacturers and service providers to expand their reach in healthcare markets. HIP adds value by offering control over regulatory needs and facilitating product commercialization in target markets.
Industries
Nr. of Employees
small (1-50)
Healthcare International Partners
2750 SW 145 AVENUE, SUITE 101, MIRAMAR, FL 33027
Products
3-ply disposable surgical mask (box of 50)
Three-layer non-woven disposable mask with a polypropylene outer and inner layer, a filter intermediate layer and a nasal bridge strip and ear loops; listed in the FDA device registry according to the product page.
KN95-type protective mask (set of 2)
Multi-layer protective mask reported as having four layers of non-woven materials with a nasal bridge strip and ear bands; described on the product page as listed in the FDA registry.
3-ply disposable surgical mask (box of 50)
Three-layer non-woven disposable mask with a polypropylene outer and inner layer, a filter intermediate layer and a nasal bridge strip and ear loops; listed in the FDA device registry according to the product page.
KN95-type protective mask (set of 2)
Multi-layer protective mask reported as having four layers of non-woven materials with a nasal bridge strip and ear bands; described on the product page as listed in the FDA registry.
Services
Consulting to create market entry roadmaps and regulatory strategies across product categories for target jurisdictions.
Compilation and electronic submission of regulatory dossiers required for product registration and facility listing.
Acting as local representative or authorized agent with regulatory authorities for communications, submissions and follow-up.
Adverse event reporting processes and vigilance reporting to support post-market safety obligations.
Services to support trademark protection activities in target jurisdictions.
Strategic commercialization services including market access planning and coordination with local affiliates and distributors.
Consulting to create market entry roadmaps and regulatory strategies across product categories for target jurisdictions.
Compilation and electronic submission of regulatory dossiers required for product registration and facility listing.
Acting as local representative or authorized agent with regulatory authorities for communications, submissions and follow-up.
Adverse event reporting processes and vigilance reporting to support post-market safety obligations.
Services to support trademark protection activities in target jurisdictions.
Strategic commercialization services including market access planning and coordination with local affiliates and distributors.
Expertise Areas
- Regulatory strategy and submissions
- Pharmacovigilance and medical device vigilance
- Market entry and commercialization in Latin America and the Caribbean
- Regulatory agency liaison and local representation
Key Technologies
- Regulatory dossier preparation and submission workflows
- Adverse event reporting and pharmacovigilance workflows
- Emergency use authorization submission processes
- Regulatory intelligence and monitoring systems