Overview Expertise Advantages Testimonials Overview Biological medicinal products are promising solutions in the prevention and treatment of several life-threatening, chronic diseases, and health conditions that cannot be managed with the help of normal pharmaceutical products. Some of the examples of health crises where biologics are proven to be the best solutions are diabetes, cancer, autoimmune diseases, microbial infections and, so on. Today, the need for specialized Biologics Regulatory Affairs is not only recognized by large traditional pharmaceuticals but also virtual companies in their quest to successfully develop and market large-molecule (biologic) therapies. Biological medicines are generally made from human and/or biological materials with the help of modern biotechnological methods such as recombinant DNA technology and advanced cell culturing. At present, the majority of biological products are produced using genetically engineered bacteria, yeast, fungi and mammalian cells with a multi-step process that involves advanced cell culturing, purification and characterization techniques resulting from scientific innovations. There are various types of biological medicinal products that include but are not limited to the following: Vaccines (for example, DTP vaccine, MMR vaccine, HPV vaccine, PCV vaccine, Typhoid vaccine, Polio vaccine & Hepatitis B vaccine) Recombinant therapeutic proteins and monoclonal antibodies (for example, GCSF, Erythropoietin, Insulin, Infliximab, Etanercept, Bevacizumab, Rituximab, etc.) Blood and sera products (for example, human immunoglobulins, anti-snake venom, anti-tetanus toxin sera, anti-diphtheria toxin sera, etc.) Cellular and gene therapy products (for example, Cord blood product and genetically modified viral therapies) Advantages of Biological Medicinal Products Biological medicinal products act on specific systems/cells/organs of the human body and show their efficacy with minimal or acceptable adverse effects, which is normally not possible with other pharmaceutical products. This high specificity has become a great advantage in treating chronic diseases like cancer and autoimmune disorders. Some of these biological products are used to manage health crises that result due to a deficiency of certain metabolic proteins/factors in the human body. (e.g., Insulin and GCSF) Specific or whole parts of a microorganism are used as an immunological agent (vaccine) to induce active immunity in the human body. These products play a vital role in the prevention of many life-threatening diseases such as polio, pneumonia, typhoid and cholera. Regulatory Hurdles in the Approval of Biological Medicinal Products Due to the complexity of biological products, Regulatory requirements for the approval of these products vary based on the product type and require submission of extensive data to support their quality, safety and efficacy. Globally, Regulatory agencies evaluate biological products for approval on a case-by-case basis with a risk-based approach, due to which the fulfilment of Regulatory requirements for biological medicinal products has become a big challenge for the industry. Freyr Expertise Freyr has a well-established infrastructure and expertise in Biologics Regulatory Affairs to provide the necessary Biologics Regulatory services for marketing authorizations and the required lifecycle management (LCM) support for various biological products in the global market. Freyr’s Biologics Regulatory Affairs experts have experience in every phase of a product’s life cycle from the initial R&D stage and non-clinical studies to clinical studies, marketing authorization and post-approval LCM. Freyr’s Biologics Regulatory Affairs team contains a good pool of industry and ex-Regulatory Agency experts with more than 25 years of experience. We believe that understanding Regulatory requirements in the right way is the key to success in today’s global market. It saves company’s time, efforts and investments. Pre-submission Support and Guidance Early stage Biologics Regulatory services and Biologics CMC consulting Strategic Biologics Regulatory Affairs consulting and Regulatory support for the submission of biological products’ Marketing Authorization Applications (MAA) Product evaluation for suitability under expedited programs, and Biologics Regulatory services for the submission of expedited program requests (fast track, breakthrough therapy, accelerated approval, priority review, PRIME etc.) Product evaluation for suitability under Orphan Drug Designation, and Regulatory support for submission of Orphan Drug Designation requests Regulatory support during pre-submission meetings and various Agency interactions (US FDA CDER /CBER, EMA etc.) Regulatory Services for USA & Europe Regions Regulatory gap analysis (review of product data), preparation of Regulatory mitigation plans and Regulatory strategies for 351(a) BLA submissions, 351 (k) BLA submissions and MAA submissions. US Agent Services for Various Developmental Programs and Applications Biologics CMC writing in eCTD format for clinical trial applications (INDs/IMPDs) and MAAs/Biologics License Applications (BLAs) Regulatory publishing and submissions in eCTD/NeeS format Biologics CMC query responses/ information requests and end-to-end support for managing Complete Response Letters (CLRs) Product life cycle management and need-based Regulatory support (e.g., biological product deviation reports submission) Change controls management & CMC variations/supplements/amendments Biological master file services for submission of information about the process, methods and other advanced technologies (e.g., gene sequencing techniques) that are proprietary in nature Regulatory Services for ROW Market (Asian, African, Latin America & CIS regions) Regulatory strategies, country-specific Regulatory gap assessment for biological products registration Compilation of product dossiers and query responses in the country-specific format Change-control management & CMC variations/supplements/amendments Product lifecycle management and renewals Regulatory Support for Biologics GMP Compliance (USA, Europe & ROW) Interpretation of the current GMP requirements/regulations for various biological products like, GMOs, recombinant proteins, cell-cultured based products, viral vaccines (live and inactivated) and supporting client in designing GMP systems and procedures (compliance against 21 CRT[BCA1] Part 210, 211, Parts 600- 680, Eudralex Volume 4, etc.) Regulatory Services for Vaccines Prequalification by the WHO Product gap assessment for WHO prequalification Regulatory strategies development for vaccines prequalification Compilation of Products Summary File (PSF) & query responses Handling of variations Prequalified Vaccines Annual Reports (PQVARs) submission End-to-End Regulatory Services for Biological Products Launch in the Indian Market The marketing authorization of a biological product in India follows a typical process and requires approval from various Regulatory entities like the Review Committee on Genetic Manipulation (RCGM), Genetic Engineering Approval Committee (GEAC) and Central Drugs Standard Control Organization (CDSCO) depending on the nature and type of the product. Freyr provides end-to-end Regulatory support for the development, marketing authorization and lifecycle management of biological products manufactured within India as well as products imported from abroad. Freyr Advantages Best-in-class CMC understanding with pharmaceutical dosage forms such as injectable (sterile solutions, powder for injections and pre-filled syringes) Comprehensive evaluation of dossier from the assessor’s standpoint Successful filing strategy with “first-time-right” outputs to ensure timely approvals Evaluation of documentation as per the recurrent changes Progressive functioning models Global service delivery competence for advantageous cost alignments Round-the-clock support Companies may not realize it today, but biological medicinal products create huge opportunities around the globe, especially in sustainable markets such as the USA and Europe as well as in emerging markets like Mexico, Brazil, China, Russia, and India. Although the scope for business growth in this market is predicted to be excellent, the evolving Regulatory aspects associated with it cannot be overlooked. For companies to expand their global footprints in new geographies, it is necessary to meet the Regulatory requirements right on time. Companies should understand that if the opportunities are more, so are the Regulatory challenges. Dedicated partners providing CMC services for biologics can rescue them from these uncalled hurdles with their years of expertise and steadfast solutions.