Consultancy
Compliance for the Regulated Industries
Experience, competence and dedicated experts, train your workers and
provide regulatory filling for biotech, pharmaceutical,
medical device, diagnostic and food companies.
We support product development and registration in the EU, North America and Worldwide.
For Drugs and Biologicals we Assist:
Application and Submission Services
- Assistance with Regulatory Strategies and Assessment of Drug Development Program
- Preparation of Submissions - DMF, IND, NDA, ANDA, BLA, CTD
- Special Meeting Scheduling and Briefing Package Preparation
- Application Amendment and Supplement Preparation and Submission
- FDA/EU Liaison
Non-Clinical
- Assistance with Regulatory Strategies and Assessment of Drug Development Program
- Preparation of Submissions - DMF, IND, NDA, ANDA, BLA, CTD
- Special Meeting Scheduling and Briefing Package Preparation
- Application Amendment and Supplement Preparation and Submission
- FDA/EU Liaison
Clinical
- Assistance with FDA's GCP Requirements for Sponsors, Monitors, and Clinical Investigators
- Good Clinical Practice (GCP) Audits/Monitoring, Data Integrity Audits
- Statistical Reports
- Good Clinical Practice and Human Subject Protection Compliance
Application and Submission Services
- Assistance with Regulatory Strategies and Assessment
- Preparation of FDA Registration and Listing, US Agent for FDA Requirements
- Liaison with FDA for Pre-submission or Special Meetings
- Assistance with FDA's Requirements for Sponsors, Monitors, and Clinical Investigators
- Guidance in Development of Briefing Package for FDA Meeting
- 510(k), IDE, PMA Preparation and/or Assistance
- Preparation and/or Assistance with Submission Amendments and Supplements as well as Required Reporting Records
- Development of Strategies for Advisory Committee Meetings
- Assistance in CE Mark Submission
Cometitve Information Management and Analysis
- On going monitoring and analysis of the business and scientific/technological environment to create a the continuous link between information and strategic business development.
- Identify partnering opportunities and potential cooperation candidates in support of technological and marketing synergies creation to maximize value.
- Strategic consulting - incorporating market opportunities and technological innovation into business strategies.
- Design and implement in house competitive research management programs.
- Function as a regulatory, business and scientific information resource for the life science community performing in depth computerized information retrieval designated to answer any question.
- Conduct in house workshops on: life science computerized databases, information resources and research techniques, competitor information and knowledge management, patent information retrieval strategies.
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