Freyr is a pioneer and innovative global Regulatory consulting company supporting global Pharma, Consumer Healthcare and Life Sciences companies to comply with FDA and EMA regulations. We offer highly cost-effective, technology-enabled Regulatory consulting services to create an optimal roadmap for our Global Top 5 and Fortune clients.
Freyr specializes in helping Life Sciences companies with distributed and de-centralized Regulatory departments to come up with a more centralized Regulatory Operating Model. Our information management system identifies the gaps, understands the short and long term recommendations and interfaces Regulatory systems with other functions like clinical, labeling, manufacturing and QMS.
Freyr’s innovative solution enables the regulatory experts to gather and analyze the latest updates in the Regulatory and compliance rules and regulations. We communicate, modify and update the documented data of the Life sciences firms in tune with the current regulations.
Freyr is ISO 9001:2008 & ISO 27001:2013 certified company and has well-defined processes. Our projects are successfully audited by senior auditors from Top 10 Pharma customers and our top management team has previous exposure to global Regulatory compliance audits as well as internal process implementation programs.
Freyr’s Regulatory Consulting Expertise:
Product, Market & Regulatory Pathway Strategy
As a key function of Freyr’s Regulatory & Business Consulting offerings, we offer Large & Small-Medium Life Sciences companies the benefits of cost-effective, consulting services to help them with the ‘right regulatory approach’.
Various parameters are evaluated to provide the right regulatory strategy. A few of them are outlined below.
- Past history and pattern of Regulatory approvals, re-calls and rejections for respective products, to the Health Authority / Market to which approval is being solicited
- The appropriate Regulatory pathway when regional complexities are present (e.g.: EU – National Procedure, De Centralized Procedure-DCP, Mutually Recognized Procedure-MRP )
- Appropriate Submission format approach
- Ongoing tracking of Ingredient-level / Safety & Scientific information services to help in better product / formulations strategy from a Regulatory perspective
- Monitor changing legislation as it relates to Toxicology, Regulatory, Environmental, etc.
- Evaluate Regulatory impact to products for safety (i.e., Cosmetic Ingredient Review – CIR, EU Scientific Committee on Consumer Safety – SCCS, etc.), constituent regulated limits, (i.e., OTC monograph, EU Cosmetic Directives, China regulatory reform), etc.
- Verification of Trade Name, Manufacturer, INCI(s), CAS/EINECS #, and percentage or constituent
- Evaluate potential impact on new guideline or restriction and/or reporting/documentation requirements
Freyr specializes in helping Life Sciences companies with distributed and de-centralized Regulatory departments to come up with a more centralized Regulatory Operating Model
Key drivers for Centralizing regulatory functions are
- Better visibility
- Harmonization of processes and information, resulting in reduced redundancies
- Ability to ‘fork-lift’ centralized functions to be outsourced or offshored
- Increased operational, process, and information management efficiency
- Significant cost reductions
- Reduce duplication of Regulatory software and other systems that may be used in ‘silos’
- Better compliance
Freyr can help design a Centralization Program and support in implementing centralization of the following key Regulatory functions
- Centralized Dossier Preparation / Life Cycle Management
- Publishing & Submissions
- Regulatory Information Management
- CMC & Change Control
- Labeling & Artwork functions
Freyr employs a low-cost Global Delivery Model – a combination of Onsite and Offshore activities to provide best cost impact to our clients.
Regulatory Information Management Consulting
In spite of having different types of Regulatory software systems, Data, and Documents required for Regulatory functions & submissions are quite distributed and sometimes even available in ‘silos’
Freyr’s Regulatory Information Management consulting practice helps companies to,
- Assess & identify gaps, if any, in the current Regulatory Information and Software landscape
- Understand short-term and long term organization objectives, regulatory requirements, and budgetary limits
- Provide short-term and long-term recommendations and solutions (could be purely a software solution or a combination of Processes & Software enhancements)
- Interfacing strategies and implementation recommendations between Regulatory systems and other Systems (QMS, Clinical systems, Labeling, Manufacturing systems)
- Assess regulatory data quality and provide operating models to clean-up data and process / system enhancement recommendations for ensuring ongoing data accuracy
- Regulatory Data Governance models
- Meta – Data update and management for Regulatory Dossiers (enabling re-use of documents and easy archiving and search)
Regulatory Intelligence Services
As a part of Freyr’s Regulatory Intelligence Platform / Services (RIS), regulatory experts gather and analyze publicly available regulatory information. This includes communicating the worldwide reach of regulations, pharmaceutical updates using a system, and monitoring the current regulations, guidance, policy, and legislation. The regulatory process includes:
- Search and Collection of applicable documentation
- Summarizing the information
- Modifying current practices, regulatory strategy ,opinions or recommendations etc. based on new information
RIS offers a complete spectrum of comprehensive Regulatory Intelligence Service categories as follows:
- Product Type : Drugs, Devices, Biologicals, Veterinary Products, Consumer Products, OTC Products, Nutraceuticals
- Regulation Category : New Guidelines, Guidelines Amendment, Pharmaceutical Development, Manufacturing, Quality, Clinical & Non Clinical, Stability & Storage, Validation, Packaging & Labeling, Pharmaceutical excipients, Impurities, Artwork & Promotional Material, Recall alerts, Safety & Pharmacovigilance, Warnings, Submission Formats, Others
Freyr INSIGHTS is a regulatory intelligence solution that provides instant access to an entire range of authoritative regulatory information for informed decision making and to create superior submissions and market strategies. Freyr INSIGHTS is built to help you quickly track, analyze and present granular insights and real-time intelligence for your compliance function.
Learn more about Freyr INSIGHTS – Regulatory Intelligence Solution
Regulatory Process Consulting
One of the core DNAs of Freyr is a ‘Consultative’ & ‘Creative’ approach to all our engagements. Many of Freyr’s Management & Operational team members come from a consulting background. We constantly look for innovative ways to enhance and optimize our customer’s processes in all the Regulatory & associated functions.
Freyr has a dedicated practice on Regulatory Process Consulting and has engaged in several strategic and process harmonization projects for Fortune Pharma companies. The primary goal of these projects were to improve overall compliance across the R&D organization.
Freyr also supports Agency Audits of our customers, where the audit scope involves Freyr’s role and services.
Freyr, being an exclusive Regulatory-focused company, has well-defined processes, enabling process adherence and audit functions as key to our services and solutions back-bone. Freyr is also ISO 9001:2008 & ISO 27001:2013 certified. All of Freyr’s projects follow a robust process / SOP backbone, independently monitored by a core QA group.
Freyr’s projects have been successfully audited by senior auditors from our Top 10 Pharma customers. We have been successful in aligning our internal compliance and process requirements (for ISO and other internal audits) with that of our customers’.
Successful Centralization across Multiple Markets for One of the Global Top 5 Consumer Healthcare CompaniesFreyr helped global client with Improved Process Efficiency via Process Standardization best practices and ensuring organization wide support.