Our Services

Regulatory and Quality Compliance

Medical device regulatory compliance is constantly changing. Many companies find it hard to stay on top of these changes which hinders their ability to get to market quickly.

At Agape-Life we have experience with regulatory bodies in over 30 countries. Medical device regulatory process can be efficient and smooth when you work with experienced strategic consultants.

Our international team works with you to create an effective regulatory strategy that combines your goals, the current regulatory environment in the region, and thorough market assessment of the country.

What can we help you with?

Regulatory (strategy, operation)

 Quality compliance (ISO13485, EU MDR, MDSAP

Clinical Trial Management

Reimbursement & health economic/pricing,

Market Access and Distribution Search

 IP management

Translating from concepts to prototype

Translating from product through R&D to commercialisation processes

Clinical Trial Management

Medical device trial designs and operations require thoughtful planning and execution to ensure the acquisition of sound scientific evidence. We provide Full-service Med Dev CRO in clinical trial management along with Clinical Evaluation Report crafting and creation for EU, USA and Asia.

Our collaborative approach, comprehensive planning, creative problem solving, and experienced consultants can save you time and money during the operational phase of your project.

We have the experienced associates that can make the difference in the success of your study, including medical device data management, medical device trial design, and medical device biostatistics.

We tailor data management services to your specific needs, creating a flexible and customized solution. Because our staff have vast and deep experience across many clinical trials, we quickly pinpoint areas for improvement, identify unusual findings in the data, and work with you to anticipate and overcome challenges.

What can we help you with?

Pre & Post Clinical Study Strategy and Management

Clinical Protocol Writing

Clinical Evaluation Report (CER)

Pre clinical animal study

Clinical Study SOP

Medical Writing

Reimbursement & Health Care Economic

We provide personalized reimbursement services by determining the product-specific coverage, coding and payment requirements necessary for: clinical trial reimbursement, market access, and market sustainability and executing to fulfill those requirements.

Our team compares your business plan to your reimbursement status and identifies the business implications. We base this on a deep analysis of the coding, technology assessment and coverage related to the product.

We then create a strategic reimbursement plan from the due diligence to address any barriers identified and guide execution. Business-process integration ensures the lowest cost of implementation.

What can we help you with?

Reimbursement due diligence

Negotiation and advocacy with Reimbursement Agency

Strategic reimbursement planning

Healthcare economic evaluation

Go-To Market and Distribution

The Medical Device industry is in a constant state of change and growth with ongoing technical advancements and the development of improved medical devices. To face these major changes in trends and to enhance the efficiency of operations, it is imperative that medical device companies create effective market intelligence solutions.

It can be a challenge to find a qualified, trustworthy Asian medical distributor. It is crucial to know the right questions to ask and conduct extensive research to ensure due diligence.

Our customised medical devices solutions reflect the newest market trends, key challenges, and untapped avenues across the medical devices industry. With our experience in industry analysis and vast network of Med Dev veterans located throughout major cities in Asia we are able to offer you Market Intelligence & Go-To-Market Solutions that will help you focus on innovating offers and identify growth opportunities.

What can we help you with?

Go-to-Market Execution and Implementation

Market intelligence

Market opportunity assessment

Go-to-market strategy

Go-to-market execution and implementation

Distributor search, evaluation       and  audit

IP Management

In a knowledge-based economy, the protection of Intellectual Property (IP) is of utmost importance. A company’s Intellectual Property is one of the most valuable assets for creating and sustaining enterprise competitiveness.

Thorough IP management is essential to prevent “free riding” from other competitors and to provide strategic opportunities for growth and global competition — category-leading products, enhanced market share and high margins.

At our teams of seasoned IP lawyers and experts review your current IP assets to help develop an effective management strategy that protects current assets, leverages assets to increase market value, and avoids IP rights infringement.

What can we help you with?

IP management (create, protect, manage)

Avoid infringement IP rights

Establish exclusive rights to commercialisation on specific technology