REGULATORY AND QUALITY COMPLIANCE
MedTech / HealthTech Product 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 18 Asia + (US, EU) countries.
The MedTech-HealthTech Product regulatory process can be efficient and smooth when you work with experienced strategic consultants.
Our international team works with you to create an effective market-regulatory strategy that combines your goals, the current regulatory environment in the region, and thorough market assessment of the country.
WHAT WE CAN HELP YOU WITH:
- Regulatory Strategy & Intelligence Report.
- Clinical Evaluation Report (CER).
- Regulatory Operation (Product Registration, Local Representative & Import Services).
- Quality System Compliance (QMS installation - Software, ISO13485, EU-MDR, MDSAP Audits & Gap Analysis).
- UDI & Implementation.
CLINICAL TRIAL MANAGEMENT
MedTech / HealthTech Product Trial Designs and Operations require thoughtful planning and execution to ensure the acquisition of sound scientific evidence.
We provide a full-serviced MedTech / HealthTech CRO in clinical trial management along with Clinical Evaluation Report crafting and creation for Asia (18 countries).
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 data management, human clinical trial design, pre-clinical trial design (animal study) and 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 WE CAN HELP YOU WITH:
- Human Clinical Study Strategy and Management (From Phase I to IV & PMS).
- Clinical Protocol & Medical Writing / Translation to In-country Language.
- Clinical Evaluation Report (CER).
- Pre-Clinical Animal Study & Design.
- Real World Evidence Study Design & Management.
- De-centralize Clinical Study with Remote Monitoring Software (EDC, CRM, AI Combine etc).
REIMBURSEMENT AND HEALTH CARE ECONOMIC / PRICING
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 fulfil 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.
We spend time in researching the right pricing for you before launching your product in the Asia market. This ensures your optimal economical returns.
WHAT WE CAN HELP YOU WITH:
- Reimbursement Due Diligence.
- Strategic Reimbursement Planning.
- Negotiation & Advocacy with Reimbursement Agency.
- Healthcare Economic Evaluation.
- Advisory Consulting.
- Finding the Right Product Pricing to Launch into the Market.
Market Access and Distributor Search / Due Diligence
The MedTech / HealthTech Industry is in a constant state of change and growth with ongoing technical advancements and the development of improved MedTech-HealthTech Products.
To face these major changes in trends and to enhance the efficiency of operations, it is imperative that MedTech / HealthTech 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 MedTech / HealthTech product solutions reflect the newest market trends, key challenges, and untapped avenues across the MedTech industry. With our experience in industry analysis and vast network of medical veterans located throughout 18 major cities in Asia, we can offer you Market Intelligence & Go-To-Market Solutions that will help you focus on innovating offers and identify
growth opportunities.
WHAT WE CAN HELP YOU WITH:
- Reimbursement Due Diligence.
- Strategic Reimbursement Planning.
- Negotiation & Advocacy with Reimbursement Agency.
- Healthcare Economic Evaluation.
- Advisory Consulting.
- Finding the Right Product Pricing to Launch into the Market.
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.
Our team of seasoned IP lawyers and experts can review your current IP assets to help develop an effective management strategy that protects current assets, leverages assets to increase market value, and avoid IP rights infringement.
WHAT WE CAN HELP YOU WITH:
- IP Management (Create, Protect & Manage).
- Avoid Infringement IP Rights.
- Advisory Consulting.
- Establish Exclusive Rights to Commercialisation on Specific Technology.
Product Medical Training and Education
Continuing medical education in the medical community is “the Hallmark of Adult Education”.
Many product manufacturers are encouraged to organize educational programs to meet the needs of Health Care Practitioner (HCP) in applying their products in the healthcare environment.
Our educational program enables companies to build a structured and systematic approach to put in place an effective education program as a continuum of education to achieve the breadth and depth of the trained footprint goals.
Our program is built on the context of a medical education service partner where in today’s healthcare environment is met with tremendous challenges in increasing demand, higher expectations on compliance quality and professional execution along with limited resources.
Companies could have invested significantly in education as it is a cornerstone of success in a company’s development, while there are significant gaps in the understanding and execution of the programs. Some gaps can be found in:
- How many HCPs participating are new HCPs?
- Is there a history database? Or is it lost every time a change of Sale Rep?
- Are the current courses effective? How do we measure them?
- Do we keep a history of HCPs attendance of courses?
- Is there a development plan for the HCPs?
- Is our current execution efficient?
- Is investment effectively spent? Any opportunity cost?
- Can be better differentiated? In Technologies or Application?
WHAT WE CAN HELP YOU WITH:
- Custom Build a Medical Education Platform for your Healthcare Practitioners (HCP).
- Develop Software to Track the Outcomes Training Effectiveness of Your Customer/HCP.
- Plan/Execute Training Program.
- Provide Qualified Trainer/s to Support your Training Program (in all MedTech or HealthTech Fields).
R&D and Contract Manufacturing
The MedTech-HealthTech Industry is in a constant state of change and growth with ongoing technical advancements and the development of improved MedTech-HealthTech Products.
To face these major changes in trends and to enhance the efficiency of operations, it is imperative that MedTech-HealthTech companies create effective R&D process and the support of a good Contract Manufacturers.
Our customised MedTech / HealthTech Product Solutions reflect the newest market trends, key challenges, and untapped avenues across the medical industry.
With our experience in the medical industry (with >20+ years) and vast network of MedTech / HealthTech veterans located throughout 18 major cities of Asia, we are able to offer you effective Research and Development pathways coupled with a regulatory compliance ISO13485 contract manufacturer; high quality medical product can be developed in the shortest amount of time to serve the noble purposes of helping mankind.
WHAT WE CAN HELP YOU WITH:
- Define & Implement Product Development Process (PDP) for Asia Markets.
- Incubation: Develop & Transform Concept into a Prototype.
- Acceleration: Transform your Prototype into Product & Commercialization.
- Investing: Help Investors Manage their Investments Effectively.
- Investing: Transform your Prototype into Product & Commercialization.
