www.freyrinc.com
Freyr Corporate Identity
Philosophy Our deep domain knowledge in regulatory, safety, clinical functions (process, data, regulations and technology), operational excellence in high-value and low-cost services and a passion for innovative solutions and services, constitutes the DNA of FREYR.
We believe in the same philosophy that you do: to make lives ‘Better’, ‘Healthier’ and more ‘Prosperous’.
Freyr is a specialist strategic consultant catering to
We pride ourselves with a diverse and global team
companies within the Life Sciences Sector across
of life sciences experts with industry knowledge,
global markets. At Freyr, we focus on positive
exposure
change, and believe in delivering value through
consulting background & technology know-how.
simplicity. We strive to achieve excellence in the
Our deep domain knowledge in regulatory, safety,
work we do and progress a step ahead to envision
clinical functions (process, data, regulations and
the trends and inculcate it in our offerings, the
technology), operational excellence in high-value
success of which we measure in the success and
and low-cost services and a passion for innovative
satisfaction of our customers.
solutions and services, constitutes the DNA of
to
global
regulations,
strategic
FREYR. We believe in the same philosophy that you do: to make lives ‘Better’, ‘Healthier’ and more ‘Prosperous’.
Competency Freyr is dedicated to enabling effective collaboration and implementation of streamlined work flows in the life sciences domain
Regulatory Solutions & Services
Software Solutions
Other Services
Freyr is dedicated to enabling effective collaboration and implementation of streamlined work flows in the life sciences domain. We deliver simplicity through design, creation through skill and delivery through trust. We are change agents; we simplify the Regulatory Processes, Pharmacovigilance services, Document Management and Regulatory Submissions, so that our clients may work more and worry less. We specialize in a wide variety of software solutions & regulatory services ranging from EVMPD / IDMP, eCTD, Electronic Trial Master File, Regulatory Document Management, SPL, Safety Case Processing Services, Regulatory Submissions Outsourcing, Global Regulatory Affairs & Strategy Consulting, Product Registrations Management to Regulatory Services Outsourcing. Freyr also offers an over-arching platform of End-to-End Regulatory Drug Safety Case Processing services. Information Management &
Regulatory Solutions & Services Regulatory Smart Sourcing Skilled and experienced Regulatory Experts Best Practices Approach Regulatory Information Management
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Standards based approach to Regulatory Data and Documents Global Regulations know how Established expertise in multiple products
Electronic Submissions Publishing SPL Conversion Services NDC labeler Code registration Establishment Registration Drug listing & Content of labeling
eCTD Submission Services Submission Plan Development Submissions Document Development Submissions Compilation & Assembly Submissions Review & Delivery
Global Regulatory Operations Compliance Quality Timeliness Cost Effectiveness
Regulatory Solutions & Services
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Regulatory Information Management Freyr Regulatory Information Management
We provide a coherent, transparent & uni-
experts help Life Sciences companies sup-
fied view through our integrated Regula-
port their regulatory information workflow
tory Information Management solution,
from nascent Research and Development
which helps drive harmonization, promotes
stages through Market Authorization and
standardization, improves collaboration, en-
post-market regulatory commitments, to
sures compliance, eliminates redundancies,
achieve regulatory operational excellence.
reduces costs, accelerates product release
and finally, allows our clients to operate and
compete more effectively in global markets.
Global Regulatory Affairs & Consulting Regulatory Strategic Consulting Regulatory Component Authoring Global Strategic Regulatory Capabilities
Software Solutions Freyr EVMPD Management
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State-of-the-Art Navigation & User Interface Components Assured Data Security from Creation to Storage Modular Component based Granular Authoring Comprehensive Security and Workflow Features Reference Lookups Lifecycle Management
Freyr eTMF Clinical Document Management Compliance TMF Consistency & Quality Accountability
Freyr Regulatory Document Management Software Metadata Integration 21 CFR Part 11 Compliance Sophisticated Visual Workflow Functionality
Ensure on-time Authoring, Review and Approval of Documents Electronic and Digital Signature Capabilities Connect Departments involved in Submission Global Repository of Documents
Other Services Pharmacovigilance Services Case Management Medical/Safety Literature Services Safety Database & Safety IT PV Smart Sourcing Global Aggerate Report Development Signal Detection & Management
Freyr eTMF Services
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Build an eTMF Roadmap for studies using Industry Standardized Reference Model Determine which TMF components will be created and captured Add company specific components Build Single, Unified list of TMF artifacts
Standardize the collection, storage and management of TMF components
Define clear roles and responsibilities regardless of trial or therapeutic area Enable development of consistent SOPs and Training
Build consistent naming conventions and structure of TMF to facilitate collaboration among project team members
Strengthen TMF Collaboration between CROs and Sponsors Measure and Track Trial Document Metrics
Other Services Freyr EVMPD/ IDMP
Cosmetic Product Safety Information
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Assess Organizational Readiness
Cosmetic Product Safety Report
Develop Strategy & Implementation Roadmap
Cosmetic Product Safety Assessment
EVMPD/ IDMP Process Implementation
Regulatory/Aggregate Reports
Other Engagements XEVMPD Activities Eudravigilance Notification
Provide safety inputs for Formulation and development of products in BA/BE studies Develop and maintain quality systems for regulatory audits/inspection Responsible for SOPs, Work Instructions
Signal Detection, Report Generation and Review Inputs Various process templates preparation RMP and PSUR Standardization Regulatory Communication
Support EU QPPV on Pharmacovigilance Requirements
Agreements and Country Representatives Management in Europe Prepare Pharmacovigilance System Master File (PSMF) Support CTMS, CDM, Clinical Trials Provide safety input to the marketed products Scientific and clinical support
Adaptability Freyr believes in enriching customer experience by
each of the businesses. With over thousands
offering customized solutions. Freyr offers tailored
of global submissions under our belt, we have
implementation with regards to regulatory services
successfully aided companies worldwide with
and consultation,
documents, submissions,
their submission requirements and compliance
cosmetic safety, pharmacovigilance services and
needs. Freyr solutions are highly customizable
data. We believe that every business is niche in
and adapt to your processes and procedures.
its own sense and hence we provide the relevant solution for
“
Freyr solutions are highly customizable and adapt to your processes and procedures.
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www.freyrinc.com
US: 103 Carnegie Centre, Suite 300, Princeton, NJ - 08540, Phone: +1 908 345 5984 . North America Operations Center: 1 Farr View Dr, STE 5E , Cranbury Township, NJ 08512. India: Global Operations Center, Lanco Hills Technology Park, Manikonda, Hyderabad, India. Phone: +91 9390112513. E-mail: contactus@freyrinc.com
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