Freyr Solutions

We offer eCTD Submission & Publishing services to Life Sciences Industry for approval of Drugs/Medicines, Converting Non-eCTD format/Paper to eCTD format to comply with FDA, EMA, Health Canada, Swissmedic, SFDA, MOH, MCCZA, Thai FDA, TGA 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. Freyr as an end-to-end eCTD  Regulatory software  provider...

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 ...

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. Strategic planning for a global clinical trial during development of a product Strategic planning for entering various regions across the globe Strategic planning to take the products approved in one region to other Regulated markets (for example, the USA to Europe or vice versa) Stability study planning for all possible presentations / container closure system Identification of reference medicinal product as per the global commercialization plan and defining the Regulatory route maps S...

Regulatory assessment   is a key activity in registration and life cycle maintenance of Pharmaceutical and Biological products. It is important at various stages of product development such as: prior to Regulatory submission, during review and approval and post-approval of the product for global markets. Enabling manufacturers to understand the open points to be addressed and prepare the mitigation plan before Regulatory submission for any Pharmaceutical/Biological product, Regulatory assessment minimizes the possible rejections (e.g. Refuse to Receive [RTR]) from Health Authorities (HAs), delays in review cycles with deficiencies and accelerates the approval processes. Regulatory assessment/gap analysis play a significant role in various  Regulatory submissions  such as: Initial Submissions Registered Dossier Extension Legacy Product Re-Launch Lifecycle Management Electronic Conversions

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. Regulatory Change & Pharma Product Life Cycle Management

Freyr offers all types of API/Excipient initial submission services like DMF, ASMF, CEP across the globe including chemical, Fermentation, sterile and biologicals. Regulatory Initial Submission Filing Active Pharmaceutical Ingredient (API)/Excipient information separately to Health Authorities (HAs) is not mandatory. However, to maintain the confidentiality and to refer for multiple drug product applications, as a practice, manufacturers of API/Excipient file the information as Drug Master Files (DMFs), Active Substance Master Files (ASMFs), and Certificates of Suitability (CEPs) aligning with region-specific requirements. Once API/Excipient information is filed with HAs and is accepted, same can be referred through Letter of Access (LoA) to multiple applications to avoid duplication of API information for different drug product submissions. Regulatory submission requirements for API (Drug Substance)/ Excipient are very specific and different for every HA. Hence, expertise and ...

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 A...

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. Regulatory Affairs Services