Bringing your medical product into market is a long and complicated journey.
There are numbers of considerations such as market analysis, product design, proof of concepts, prototyping, tests, scale-up, process validation, generating GMP, and regulatory affairs. Even after them, marketing and sales are also required.
Many manufacturers have difficulties to cover these tremendous works, alone.
LnS can provide the expertise services working together with you. Our 20-year industry and academy career can give you confidence for your successful business.
LnS supports FDA submissions, communications with regulatory bodies, and provide your own fit guidelines and regulations. With our medical device consulting service, you maintain project control while gaining the benefit of on-demand external support.
Tissue & Cell Product
Human cells or tissue intended for implantation, transplantation, infusion, or transfer into a human recipient is regulated as a human cell, tissue, and cellular and tissue-based product or HCT/P. The Center for Biologics Evaluation and Research (CBER) regulates HCT/Ps under 21 CFR Parts 1270 and 1271.
LnS as a CTBS (Certified Tissue Banks Specialist) supports AATB accreditation, quality manual, process procedure, and validations.
New Product Development
The aim of research and development is to innovate new products and markets that improve your current and future state.
Today’s product development and R&D operations must work together to define and execute successful go-to-market strategies.
LnS will help you conduct market research, develop concepts, create prototypes, and execute tests that deeply accelerate your speed to market. After verifying and validating designs, we’ll help you develop a plan for getting your designs into production.
LnS can help medical device and biotechnology companies to establish the strategic direction of their technology platforms and market entry strategies.
New Business Development
LnS can analyze an accurate diagnosis of your business and we can create new business models for you.
We connect international business partners as your needs, and provide strategic business as fast changing market trends.
Our search team can find your supplier, business to business partners, distributors, venders, and anyone what you need.
New Grant Application
Planning strategies for grant application to government, companies, or universities is also our one of the best platforms. We completed numbers of R&D grant projects over 20 years and those projects were translated successfully to the new market.