HOW WE WORK
Hasten LLC identifies and manages the steps that the creators and/or manufacturers of Medical Devices need for each type of product under development, offering testing services for all regulatory and market requirements
PREMARKET
Advantages and benefits of contracting Hasten LLC
Global expertise generating competitive differential
Acceleration of the development of medical products and devices
Reduced time of placing the product on the market
Formatting the product for the market
Monitoring of laboratory tests and clinical research
Quality system
Support for compliance and government affairs
Feasibility of the launches of new products and technologies
Partners with more than 20 years of experience in the market
Diverse training out with multidisciplinary teams of our clients
Thousands of certified and approved products in the different countries in which Hasten is active
Executives present in the main markerts (Asia, Africa,Eastern Eurpe, United States, and Latin America)
Thousand of FDA and CE Mark certifications for manufacturers in several countries
Full support in the differente stages of the process (planing, analysis, before authorities, and continuity of the regulatory process)
SERVICES
NAMSA is Hasten LLC’s main partner for premarket operations.
Through coordinated and complementary work from this important partnership, Hasten LLC provides comprehensive consulting and evaluation services for safety and efficacy of products, services and medical equipment to developers and manufacturers which can offer safe and effective therapies to the market.
Services offered – Pre Market
Concept of products and services
Economic feasibility studies
Formatting of production processes
Regulated Manufacturing Plant (USA)
Capability and education of teams
Integrated laboratory and clinical, preclinical, toxicology, microbiology, chemistry, and quality consulting services
Regulation of products and services in regulatory agencies
Assistance and preparation for inspections of regulatory agencies
Reimbursement Consult
REGULATORY APPROVAL AND MARKETING
We simplify and streamline the medical device certification processes so that our customers can market their products and services on a global scale, optimizing human and financial resources.
We offer general advice on regulatory matters for importers and manufacturers of all types of products with agility and within the protocols of each country and market.
Hasten LLC is the exclusive partner of NAMSA — the largest Medical Research Organization (MRO®) in the world — in Latin America, which means being constantly in tune with the requirements of the world’s regulatory agencies: US FDA, Notified Bodies from Europe, Japan PMDA, NMPA from China and other international authorities.
HOW WE WORK
Postmarket: we validate the best partners for the distribution of products and services with storage and logistics capacities, in addition to a proactive and enthusiastic sales force to bring innovation to the market.
POSTMARKET
LEARN MORE ABOUT OUR OPERATION
Sales and logistics operations
Identification and accreditation of local distributors
Distribution Management
Direct & Indirect Sales Channel
Performance Management
Business Strategies and market mapping
Import advice and support
Marketing and communication
Creative and market-friendly financial solutions
Capability and training of sales teams
Access to Hasten LLC partner network