Overview In the 1990s, diversified product portfolios across medical devices, small molecules, generics, biologics, and branded drugs illustrated value. However, in recent years companies have realized the potential of having a concise product portfolio and implementing strategies with simplicity at its core. This shift in the trend was witnessed in the consolidation of 60 major life sciences companies into, 10. Pharmaceutical organizations must conduct major modifications right from the Regulatory to the end-product packaging and labeling domain for the product(s) they support. Multinational Pharmaceutical firms face much more complex scenarios, as they perform multiple product transfers. To drive these modification initiatives towards a successful execution, the organization should ensure a constant evaluation of their activities and processes and ensure they are in alignment with their company’s end goals. As most organizations fail during the initial phase of such product transition deals/decisions due to incorrect approaches, and/or unforeseen circumstances, establishing a governance plan at the get-go is crucial. To avoid errors from the beginning and at any given time of the process, organizations must ensure that they implement management plans at initial governance stage to manage the transition procedures. Establishing a Transition Management Office (TMO) will help organizations track their progress during the transition phase through a single point of contact. A TMO framework must ensure that: Transition road maps are designed from a Regulatory standpoint Strategize every phase and step involved in the transition Deals made during the process are impartial towards any merging or divesting entity Develop a resilient framework of operation for participating entities Visibility on progress is available for all stakeholders during the transition period Necessary documentation tasks are to be kept up to date Freyr’s Spin-offs, Mergers & Acquisition, and Divestitures (SoMAD) Consulting services: A successful Spin-off, Merger, Acquisition, and/or Divestiture is best supported by a resilient framework and a strong pharmaceutical technology transfer plan. A system that not only keeps up with the dynamism of the processes but is also adapted to changing strategy with the unfolding hierarchy of requirements. At Freyr, our Regulatory Strategy Consulting team understands the ins and outs of the pre-, during, and post-transition processes. Our SoMAD segment serves as a Transition Management Office while the companies establish their new identity. Freyr understands that every company and their needs are different. Our team can best help and support your company as you undergo the transition. Our Expertise Ranges Across Global organizational setup as per Health Authority obligations Future-proof market entry plan with local support in over 120+ markets Marketing authorization transfers with industry-leading turnaround time Go/No-Go decision and due diligence Plug and Play infrastructure of resource deployment Post-transition management services Throughout the transition journey, Freyr is well equipped to provide end-to-end Regulatory support to ensure the smooth running of processes, from a complete handover to the new entity, all authorizations, and positions of responsibility as and when ready. Key Considerations for NewCo (New Entity Formation) Product Portfolio Rationalization and Competency Management Evaluate + Consult: Competencies needed in local market to manage the allotted portfolio in the selected market; Current vs. future analysis Organizational entities and Authorized RepresentationEvaluate: The Local entities and their responsibilities in representing the products in market; Current vs. future analysis Central and Local Regulatory teamsEvaluate:Current and future regulatory organizational frameworkOperational focus points of the central team and local teams New Product Introductions Evaluate the current strategies for product launch in selected markets; revise as neededManaging or maintaining AR during transition; identifying strategies or evaluating the current stanceLaunch of current projects (in motion) vs. future strategies and its congruent Reg_ intelligence support analysis Product Maintenance (Regulatory Operations)Evaluate + Consult:The Life Cycle Management for the products and their Regulatory compliance; Current vs. Future analysis Regulatory Information Management and CentralizationCurrent vs. Future analysis of:Global products portfolios, submissions, registrations, commitments, data management Technology Harmonization Evaluate + Consult:Interim and Future approach for sharing, and owning technology application licensesApplication licenses for managing regulatory data Manufacturer Supply chain Distribution Interim and Future assessment of manufacturers, distributors, partners, and supply chain processes Product Portfolio Rationalization and Competency Management Evaluate + Consult: Competencies needed in local market to manage the allotted portfolio in the selected market; Current vs. future analysis Organizational entities and Authorized Representation Evaluate: The Local entities and their responsibilities in representing the products in market; Current vs. future analysis Central and Local Regulatory teams Evaluate: Current and future regulatory organizational framework Operational focus points of the central team and local teams New Product Introductions Evaluate: Evaluate the current strategies for product launch in selected markets; revise as needed Managing or maintaining AR during transition; identifying strategies or evaluating the current stance Launch of current projects (in motion) vs. future strategies and its congruent Reg_ intelligence support analysis Product Maintenance (Regulatory Operations) Evaluate + Consult: The Life Cycle Management for the products and their Regulatory compliance; Current vs. Future analysis Regulatory Information Management and Centralization Current vs. Future analysis of: Global products portfolios, submissions, registrations, commitments, data management Technology Harmonization Evaluate + Consult: Interim and Future approach for sharing, and owning technology application licenses Application licenses for managing regulatory data Manufacturer Supply chain Distribution Evaluate + Consult: Interim and Future assessment of manufacturers, distributors, partners, and supply chain processes Services Offered by Freyr Regulatory Affairs/CMC Pharmacovigilance Artwork Labeling Publishing & Submission Compliance, Audit & Validation Medical Writing Regulatory Affairs/CMC Type of Deal: Acquisition (Portfolio & Product) Commercialized product Pre-deal Closure Stage: Dossier format (CTA, NTA, eCTD), Local, Paper/Electronic (if paper, localization) Dossier Language Legal Status OTC/Rx Proprietary Name (suitability/merits, Umbrella branding) Type of Application (NCE, Generic, THMP, WEU, Hybrid, Full MAA, Other (i.e. similar) Basic Registration Data (Manufacturers, Packers, QC sites, Batch release sites, Local distributors, Trade route) MA Holder (current one) Serialization (whether applicable) Embossing (list of products with embossing and ™ printed on bulk product) Post-deal Closure Stage: Core MAT Submission (MAH change/MAH address change/MAH name change) Local LE Name Changes (impact on PIL) AW Notifications (MAH name change) Embossing on the Tablets/Capsules (removal) PSMF Update (QPPV data, PV system description) Serialization (submissions) Embossing (consequential variation i.e., removal of ™) Pharmacovigilance Type of Deal: Merger/Acquisition Pre-deal Closure Stage: Planning, Go/No-Go Decision, Post-deal Execution Blueprint Post-deal Closure Stage: Pharmacovigilance Agreements and SDEA Review PV Gap Analysis and Evaluation of Country/Geography-specific Regulations Affected by M&A Safety Database Migration and Integrations PSMF Data Merger PV QMS and SOPs Harmonization Business partners and Vendor integrations/exclusion XEVMPD/IDMP data nullification Training and Compliance of PV Personnel on Local and Global Level (inclusive of QPPV) Artwork Type of Deal: Merger/Acquisition Pre-deal Closure Stage: Planning, Go/No- Go Decision, Post-deal Execution Blueprint Post-deal Closure Stage: RA services [Initiating the Artwork requests on behalf of the country Regulatory affairs (client Regulatory team) in Artwork Management System, Annotate the required changes related to MAT, Artwork Coordination, Review and Approval of the Artwork] Artwork Creation Services Artwork Proofreading Services Artwork Co-ordination Services Assess the list of all products Collection of labels Compliance Review of Labels Population of Country Label Templates Annotation of Artwork Artwork Updation RA Review, Approval and Co-ordination MAT Transfer Submission Package Preparation Updating Artwork with Robotic Process Automation Labeling Type of Deal: Acquisition (Company) Pre-deal Closure Stage: Planning, Go/No-Go Decision, Post-deal Execution Blueprint Post-deal Closure Stage: Ownership Transfer of eCTD New Template Generation Migration of Old Publishing Sequence into a New Sequence Integrating Existing Applications into New Company Systems SPL Updates Establishment Registration Update NDC Labeller Code Updates Drug Listing Updates Company Ownership Transfer Publishing & Submission Type of Deal: Merger/ Acquisition (Portfolio & Product) Pre-deal Closure Stage: Rapid Scalability in Regulatory Submission Planning on Ongoing Development of Molecules Document Planning, Authoring and Review Pre-Approval Post-deal Closure Stage: Legacy data transfer Supporting with Regulatory Submissions Assembly Delivery of Revised Electronic Submissions Archiving Submissions to the Designated Repository and Shipping Hard Copy Versions Compliance, Audit & Validation Type of Deal: Acquisition (Portfolio & Product) Commercialized product Pre-deal Closure Stage: Organogram Restructuring Pre-deal Compliance Planning Post-deal Closure Stage: SOP Arbitration Process Architecture Merging SOP Integration and Rationalization Medical Writing Type of Deal: Merger/Acquisition Pre-deal Closure Stage: Clinical Studies/Data Nonclinical Studies/Data Data Management Tools (if any) Data Transfer Protocol/Process Details of the CROs where the Studies have been conducted Data Archival Policies Agreed with CROs List of any Ongoing Studies and the Responsibilities of CROs Post-deal Closure Stage: Any Commitments with Agencies and the Details Window Time for Overlapping Support from the Old Company or Contributors of the Current Company All Sequences of the Submissions for Different Products and how they are Managed and Transferred Agency Communications Case Studies Acquisition A British Multinational Consumer Goods company acquired pharma and OTC products from an American multinational consumer goods company. Freyr helped the acquirer meet the requirements of the HA (SOP’s, SOW’s QA/QC, evaluation of laboratory facilities, etc.) and with MAH for the acquired products. Joint Venture A leading Global British Consumer Healthcare organization underwent a joint venture with a leading Biopharmaceutical company’s Consumer Healthcare division. Freyr supported the British organization with the review, comparison, and alignment of CDS (from the Biopharma company) and GDS (from the consumer health company). M&A An American Multinational Healthcare acquired a Specialty Injectables company. Freyr supported the acquiree with artwork and Regulatory services in India. Spin-off An Australian subsidiary of a Canadian pharmaceutical divested and merged with an Australian generics manufacturer. Freyr supported the Canadian holding company with data transfer from the generics manufacturer. M&A A leading US-based generic pharmaceutical company acquired generic products from a Switzerland-based biopharmaceutical company. Freyr supported the US-based company with end-to-end Regulatory activities. M&A A leading American multinational pharmaceutical organization acquired an American global pharmaceutical and medical device organization’s consumer health portfolio. Freyr supported the acquisition with CCDS development. Acquisition An Indian multinational pharmaceutical company acquired a few pharma products from a Swiss multinational pharmaceutical and American multinational pharmaceutical company. Freyr supported the Indian pharmaceutical company with artwork, labeling, Structured Product Labeling (SPL), and publishing. Spin-off An American multinational pharmaceutical company spun off to form a new Global healthcare company. Freyr assisted with end-to-end labeling and artwork services. Spin-off A Swiss multinational company approached a British multinational company to sell off a segment of its portfolio. Freyr helped the British MNC identify the potential product portfolio and arrive at the Go/No-Go decision. M&A A Swiss multinational company underwent a spin-off to form a sub-division of a dermatology portfolio. Freyr provided support across Regulatory management harmonization throughout the spin-off.