Freyr is a leading, niche, full-service global Regulatory Solutions and Services Company supporting, Large, Mid and Small global Life sciences companies, (Pharmaceutical |Generics | Medical Device | Biotechnology | Biosimilar | Consumer Healthcare | Cosmetics) in their entire Regulatory value-chain; ranging from Regulatory Strategy, Intelligence, Dossiers, Submissions etc. to Post- Approval / Legacy Product Maintenance, Labeling, Artwork Change Management and other related functions.
Freyr provides comprehensive Regulatory services across the spectrum of global product development, registration and commercialization. We deliver informed advice and pragmatic services and solutions for new product and market authorizations, Health Authority submissions, post approvals, CMC and lifecycle management to help companies maximize their product’s commercial potential and market success.Freyr’s global Regulatory affairs expertise enables Life Sciences, Consumer Pharma and Bio-Med companies understand and efficiently manage the demanding complexity of the diverse Regulatory requirements in order to successfully launch their products in new markets and maximize the value of their assets.
Enabling life sciences organizations to meet their Regulatory goals across the globe for Pharma, Generics, Biosimilars, Vaccines, Cosmetics, OTC, Nutraceuticals/Food and Dietary Supplements, and Medical Devices, Freyr offers a full spectrum of end-to-end Regulatory services that span across strategy to submissions and lifecycle maintenance.
Freyr is a leading player in Centralized Chemistry, Manufacturing and Controls (CMC) and Life Cycle Dossier Management, offering services ranging from Strategy Consulting for CMC/Legacy Product Life Cycle Management (LCM) delivery models (Centralized), and Operational Outsourcing of CMC /Life Cycle activities. Freyr has an established Center of Excellence for Regulatory CMC and Life Cycle Management – offering CMC Services for 100s of products across various Global Health Authorities (HAs) for Top-20 Pharma / Consumer Healthcare companies.
To commercialize a product in a specific region, organizations must obtain market authorization from target country’s Health Authority (HA), which can be processed by filing an initial submission application (viz. Investigational New Drug (IND), New Drug Application (NDA), Abbreviated New Drug Application (ANDA), Biological License Application (BLA), Clinical Trial Application (CTA) and other regional applications etc.). Any application of a drug or other products submitted to a HA for the first time, with supporting documents/data in-line with geo-specific requirements, is considered as new/initial/original submission. As submission requirements are dynamic in nature and are frequently updated by HAs worldwide, the need of the hour is to track them in a continuous manner. In such scenarios, organizations opt for Regulatory Affairs to decode and understand region-specific requirements for error-free initial submissions and quick market authorizations.
Freyr is a preferred Regulatory Affairs partner for new market authorizations / initial submissions to global clients, for all types of products (New Chemical Entity (NCE) / New Biological Entity (NBE), Generics / Biosimilars, Medical Devices, Active Pharmaceutical Ingredient (API) / Bulk Drugs, Over the Counter (OTC) / Consumer Healthcare products) and formulations (solid oral, liquid oral, parenteral dosage forms, biologicals etc.). Freyr has a very strong Regulatory team having prior experience and expertise in handling market authorizations of all major HAs like, the United States Food and Drug Administration (US FDA), the European Medicines Agency (EMA), the European Directorate for the Quality of Medicines (EDQM), the Therapeutic Products Database (TPD), the Pharmaceuticals and Medical Devices Agency (PMDA), the Therapeutic Goods Administration (TGA), Medsafe, the Medicines Control Council (MCC), Ministry of Health (MoH) of Russia, Latin America (LATAM), Middle East and North Africa (MENA), Asia Pacific (APAC), Association of Southeast Asian Nations (ASEAN), Commonwealth of Independent States (CIS) regions, and World Health Organization (WHO).
The purpose of clinical trial monitoring is to guarantee that the trial data is accurate, complete and verifiable, as well as in agreement with ethical and scientific norms. The quality of clinical trial monitoring is the basis of efficient execution and the success of each clinical trial depends upon it. Robust monitoring is vital to a clinical trial, both to protect the integrity of scientific data and to yield valid Regulatory data. To ensure that this data adheres to protocols and international guidelines, the need of the hour is for organizations to opt for an expert medical writing partner who is well-versed with audit and monitoring capabilities.
Freyr has highly skilled and innovative clinical monitoring team which displays professionalism and innovative problem-solving skills while monitoring everything from straight forward, 2-way, cross over BA BE studies to large, complex, steady state BA BE studies. Freyr also provides excellent, independent, monitoring and auditing services for both the clinical and bio-analytical phases of the BA BE study through its highly qualified and experienced monitors. Our monitoring services assist in quality control during clinical trials to maintain the integrity of the trial as per specific standards like ICH Good clinical practice (GCP), the United States Food and Drug Administration (USFDA), Europe, Middle East and Africa (EMEA), The National Health Surveillance Agency or ANVISA (Agência Nacional de Vigilância Sanitária) regulations and so on. Freyr’s proactive research site approach helps you to access the best sites following a thorough audit of feasibility and analysis of the CRO/study site along with high quality monitoring of sites throughout the trial duration, to ensure compliance to applicable regulations and guidelines. Our audits and solutions are set to deliver data which is generated with integrity, and also to ensure the sponsor Regulatory compliance and approval.
As Regulatory Agencies (RAs) all over the world started implementing comprehensive Regulatory systems to control the manufacturing and usage of medicinal products, being compliant with stringent requirements is becoming a challenging issue for product registrations and drug approvals. That triggers the need for well-defined Regulatory strategies right from the product development to lifecycle management to addressing all submission requirements, and to comply with the mandatory requirements.
Without sufficient understanding on right Regulatory strategy for specific cases, many companies face delays in product registration that affect the costs. Therefore, right partner for strategic planning and monitoring Regulatory changes is the key for successful commercialization of a drug product. With a proven track record to keep abreast with global market conditions and navigating clients across through their unique Regulatory requirements, Freyr stands a preferred Regulatory strategic partner for any Pharmaceutical or Biotechnology company.
Regulatory Intelligence Services
Healthcare companies across the world require strong Regulatory support to make important decisions like expanding their product portfolio or to market their products across multiple geographies. Enroute they face critical challenges like knowing local dossier requirements new guidelines, ingredient & claim analysis, labeling & packaging requirements, import regulations, local GxP requirements, etc. In such scenarios, there is an undeniable requirement to ensure that companies are aware of these existing geo-specific regulations and also of any forthcoming guidelines to be published. It then becomes essential that Regulatory Intelligence(RI) addresses all these challenges accurately. There arises the need of accurate Regulatory intelligence and strategies to know the exact Regulatory requirement and to provide the highest quality submissions to agencies globally.
With a robust network of local affiliates in more than 120 countries and coordination with Health Authorities (HAs), Freyr’s Regulatory Intelligence(RI) team can address any query or requirement of companies across the globe. The team adheres to the best ethical practices as defined by RAPS & SCIPS, for collating Regulatory and market information from various sources.
eCTD (electronic Common Technical Document) is an electronic format that supports the submission of applications, amendments, supplements and reports to the FDA, EMA and other Health Authorities (HAs) worldwide. It also streamlines the submission process by facilitating the creation and review of electronic data, lifecycle management, and the exchange of information. By integrating the metatags, hyperlinks and bookmarks to the data, it also enables efficient assessment and navigation of Regulatory information that leads to faster reviews by HAs, thus enabling quicker market approvals/authorizations.
With a comprehensive knowledge of global Regulatory publishing trends and submission formats (for example eCTD/Non-eCTD electronic submissions [NeeS]), Freyr supports dossier submissions across the globe. For efficient, effective and multi-country filings, Freyr offers data compilation, data publishing and dossier dispatches through an in-house Regulatory publishing and submission software, Freyr SUBMIT, that supports global HA submission formats. Adhering to the United States Food and Drug Administration (USFDA), ICH HL7 standards, Freyr is a strategic partner for multiple submissions within brief timelines, which has proven to be very cost-effective for organizations.
Amid the periodic evolutions and amendments in safety monitoring regulations, maintaining the safety data of medicinal products/devices is the ultimate responsibility of Marketing Authorization Holder (MAH) to ensure the timely submissions of safety information to health authorities and renew the product registrations globally throughout the lifecycle of the medicinal products/devices in the market.
In a case where adverse events are reported, the process undergoes multiple steps including case triage/book-in, case processing, medical review, quality review and submission to Health Authorities (HAs) as Individual Case Study Reports (ICSR). The safety information is then pooled and evaluated as part of aggregate reports in the form of benefit-risk evaluation, signal evaluation, risk management, periodic safety reports, etc. Increased complexities, huge data, and evolving Regulatory standards have warranted the requirement of domain expertise on one side and huge cost involvement to maintain drug safety compliance on the other side. There arises a need of streamlined Pharmacovigilance (PV) services.
Freyr provides end-to-end PV services to guarantee optimal benefit-risk profile of the medicinal product with a goal to improve safety and achieve better patient outcomes. With a team of skilled and experienced safety and PV professionals (both medical and paramedical) from pharmaceutical and clinical research industry, Freyr demonstrates proven expertise in delivering high quality and compliant PV services for global large pharmaceutical and leading biotechnology companies of any size.
With a comprehensive understanding of the industry, and having global presence across 120+ countries, Freyr helps organizations right from decoding Regulatory pathways to providing regional Regulatory intelligence to successfully defining strategies for various health authority submissions and market approvals. In simple terms, Freyr enable organizations access the global markets with impeccable Regulatory strategies.
Market Access and Regulatory Strategy Expertise
Medical Writing is a vital segment of clinical research. It plays a critical role in the development and submission of clinical research documents and defines the success or failure of new medicinal products/devices. As Regulatory authorities expect precise and timely submissions of documents/dossier, any delay in this stage leads directly to a delay in realizing profits both in terms of achieving patient benefit and ROI.
With a qualified (Medical and Paramedical) team of skilled and experienced medical writing professionals from pharmaceutical and clinical research industries,, Freyr develops quality documents, performs peer review and coordinates client reviews, performs the quality checks, and accomplishes the project management of various Regulatory, clinical and medical writing activities. The Freyr medical writing team, with a proven proficiency in developing and delivering world-class Regulatory and medical writing services for its growing clientele of (global large) Pharma, leading CROs and other Biotech companies adheres to stringent timelines and high-quality parameters.
Artwork Pack Management
Freyr Artwork Pack Management CoE provides innovative, cost effective, creative graphic design & artwork services to support new product launches and brand re-designs for global pharmaceutical and consumer healthcare companies. Freyr’s artwork pack management services deal with Product Lifecycle Management of any product including leaflet/carton/label starting from initiation to the production of the packaging artwork.Freyr also offers artwork services for content to carton, private labeling and primary and secondary artworks that include all printed materials associated with the products e.g., containers, labels, cartons, inserts, packets, and shippers when used as primary packaging.
Freyr offers End-to-end labeling services and software support for global and regional labeling management, CCDS creation and updation, core to local label alignment etc.Our team of highly qualified medical experts track status of the data sheets implementation in local labels, review and suggest the changes to the data sheets and write the clinical overviews for submission to the Health Authorities.
Freyr offers a comprehensive range of services for global Regulatory compliance requirements for cosmetic and personal care companies to ensure their products meet the latest cosmetic safety regulations. With regional offices in Europe and North America as well as in the Middle East and North Africa (MENA) and Asia Pacific (APAC) nations plus a vast partner network spanning 120+ countries, we are uniquely positioned to support Regulatory requirements for beauty and personal care products and to ensure quality, safety, efficacy and regulatory compliance globally.
Our global team of qualified professionals and consultants have expertise in governing the manufacturing, labeling as well as supply of cosmetics and personal care products worldwide. We help manufacturers, distributors and marketers of cosmetics, finished products and raw materials worldwide in areas of Regulatory Intelligence, International Product Representation, Product Registration, Safety Assessment Reports and International Labeling Compliance.
The appropriate and timely communication with Health Authorities (HAs) is a key factor for the speedy approval and uninterrupted commercialization of a medicinal product either during initial approval or during Life Cycle Management (LCM, i.e. through post approval changes submissions). When a Marketing Authorization Holder (MAH) or applicant submits an initial or post approval activity application, upon evaluating the submitted data HAs may revert with their concerns or recommendations, if the submitted data is insufficient or requires any further clarification or for any further commitments post approval to ensure quality, safety and efficacy of the product.
Either the Information Requests (IRs), Refuse to Review (RTR), or Request for Further Information (RFI), the expertise lies in understanding the concerns, response compilation while answering, so that it avoids further queries and delays in the approval procedures. While responding to HA queries, the communication can be done in different modes based on the procedural stage and severity of the queries raised by the HAs. To prepare the response, the applicant can communicate with HAs or the HA assessor (responsible for the submission) to understand the queries in detail and to brief or explain the strategy behind for respective submission.
With a strong footprint in handling HA queries for different types of products and formulations, Freyr is proven to be a preferred Regulatory partner across the globe. Freyr has strong Regulatory team that has a thorough knowledge and understanding about the types of formulations, types of the Regulatory submissions and has a proven track record in handling HA queries pertaining to initial submissions and post approval changes/LCM of the products or administrative queries.
Publishing and Submissions
Freyr assists Life sciences organizations streamline entire Health Authority (HA) Submission Management Process, right from dossier development, submission planning, tracking, publishing and final submission to HA including Delivery Confirmation/Acknowledgement, to ensure error free, timely and quality submissions throughout the Submission Lifecycle. Freyr supports electronic, paper, eCTD, NeeS submission formats.With a flexible publishing and submission software, Freyr SUBMIT, Freyr enables companies to effectively meet all their specific and unique submission requirements for faster and efficient approval of Drugs, Biologics and Medical Devices by global HAs.
Freyr offers complete suite of Regulatory tools and software services that match client requirements; be it publishing and submissions, labeling, Regulatory intelligence, Regulatory document management, trial master files, IDMP, and end-to-end Unique Device Identification (UDI) compliance solution.Freyr’s proprietary Regulatory tools are flexible, intuitive, user-friendly, ready-to-use, efficient, secured and cloud-hosted, which enables organizations to streamline all their Regulatory activities.
• Regulatory Software and Services Expertise
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