Drug and Device Development Company has established its reputation for reliability and competency in the medical services area. Whether you are a European or North American research-focus company, consider NEW HORIZON as your extended European team of choice for the complete development of your medical products.
is to extend the capabilities and expertise of our medical device, pharmaceutical, biotechnology, diagnostic, and nutritional industry clients.
is to responsiveness, quality, partnership and teamwork.
is to successfully develop the most INNOVATIVE new therapies and to making these available to patients worldwide.
Strategic Consulting
Business Development
Clinical Trial Management
Regulatory Compliance
Quality Systems
Authorized Representative
In the medical industry, the attainment of a positive Conformity Assessment does not automatically assure successful market introduction. The perception of the device by the medical community and health care reimbursers are of central importance. The marketing and reimbursement strategy may and usually vary from one European country to the next. Recognizing and addressing the considerations and requirements at the clinical development stage can give the medical device manufacturer the decisive competitive edge in MAXIMIZING return within the product life-cycle. NEW HORIZON staff and consultants can work with you to best understand the environment into which you introduce your product.
What is the treatment disease incidence and prevalence in the target markets?
What is the local treatment demand?
Who are the health care providers and how do patients come to them?
Who are the treatment decision makers
and what are their considerations?
What treatment options are available to the treatment decision makers, and how are these perceived?
Who are your competitors and what is their image amount the treatment decision makers?
How should your product be positioned
within the available product range?
Is your product likely to be reimbursed based upon unit pricing or within drug procedure budgeting?
What is the role of the public statutory health insurance providers?
How and at what rates are comparable devices reimbursed?
What role does technology assessment have to obtain target pricing or are prices fixed?
Are there local, regional or national budgetary restrictions in the number of treatments?
The application of statistical methodology to clinical, quality-of-life and economic data to assess the value of your product compared to standard or alternate treatments.
Cost mineralization analysis
Cost effectiveness analysis
Cost utility analysis
Cost benefit analysis
Preparation of reimbursement dossiers
Enrolments of key opinion leaders
Coordination of applications with reimburses
Identification of the most appropriate, capable and competent European distribution partners.
At NEW HORIZON , we have distinguished ourselves as Clinical Research and Development leaders. Our clients have relied on us for operational support in the following areas and more:
Multi-national, multi-center clinical project management
Study protocol development, case report form design and document translations
Standard operating procedures and work processes
Clinical trial feasibility evaluation
and investigational site selection
Clinical trial insurance
Ethics committee review coordination
Clinical trial regulatory submissions
Investigators’ meeting organization Investigator & study coordinator training
Site initiations and study monitoring
Authorized representative
Product vigilance and adverse event management
Quality assurance auditing
Data management
Study reporting and publications
NEW HORIZON has a track record of efficiency, competence and success in providing our clients with regulatory affairs support at the local, Member State, European Union and United States FDA level. We have supported major multi-national corporations and innovative ENTREPRENEURIAL enterprises.
European and united states regulatory law and processes
National clinical trial notifications & authorizations
Pharmaceuticals and biologics
Site registrations
Import authorizations
Market authorization applications
Hybrid products
Product extensions
Electronic dossiers
Medical device and in-vitro diagnostics
Device standards assessment
Biocompatibility assessment
Sterilization assessment
Design control and
master file compliance
Device risk analysis
Authorized representative
Site registrations
Import authorizations
Competent authority communication
Notified body selection, coordination and management
Technical dossier development
Conformity assessment coordination
Health insurer product / procedure reimbursement
Product specific compliance strategies
Complaint handling, event reporting and vigilance reports
Within the global environment in which we develop therapeutic products, scientific and regulatory scrutiny demands transparency in the methodology applied to research, development and operational processes. Total Quality Management, customer satisfaction
and continuous systems improvement form the context of our own work and our consultancy for our clients.
Whether pharmaceutical or medical device, North America, Europe or the Far East,
NEW HORIZON staff and consultants are internationally acknowledged quality experts.
QS Process Development - Identification, Development and substantiation of infrastructurally compatible, effective and efficient Quality Systems within the TQM environment.
Process Documentation - Development and implementation
of Standard Operating Procedures and Work Process Guidelines in compliance with the most appropriate operational standards, e.g. ISO, FDA, EC, ICH, OECD, etc.
Training - Roll-Out of Quality System at a company-wide or Project
Team level.
Continuous Improvement - Adaptation of Quality System consistent with customer expectations.
Auditing - Assessment of established Quality System COMPLIANCE. The following specific quality auditing services
are available to you:
NEW HORIZON routinely provides such support to our clients both during clinical investigations and following Conformity Assessment and marketing. Simply stated, the responsibility of the Authorized Representative serves as the communication path with the Competent Authorities in each of the European Member States.
Interaction with the competent authority to confirm compliance with applicable essential requirements of the mdd and associated regulations pertaining to clinical investigations
Notifications to the competent authorities concerning
the clinical trial and associated key participants in the process, e.G. Manufacturer, sponsor, investigators, ethics committees, etc.
Safety reporting
Compliance with clinical trial insurance requirements
Importation
of the medical device into the eu
Appropriate storage and distribution, device accountability, labeling, instructions for use, maintenance, etc.
Communication with the notified body
Interaction with the competent authorities regarding all regulatory compliance issues
Notifications to the competent authorities concerning distribution and regulatory compliance
Vigilance reporting
Maintenance of technical
files for competent authority inspection
Manufacturer/distributor compliance with established quality systems