Growing Regulatory Requirements
As markets are maturing, health authorities around the world are adapting to growing safety concerns and end users wellbeing. As it is said, with great power, comes great responsibilities.
In a global environment, a biopharma company is engaged beyond the borders in not just marketing its therapies and products but also in sourcing requisite material or services from companies. Therefore, any change in regulations not only impacts the prospect of sustained supply chain through sales, but also at the level of production and supply.
Depending on the size of the portfolio of products marketed in different countries, it is a strategic decision for companies to appoint full-scale team to manage regional regulatory affairs. This is however not the case with a majority of companies. In most scenarios, companies seek out a partner with presence in those countries to manage the regulatory affairs operations for them. This further necessitates a need to have a 360 degree partner evaluation and on-boarding strategy. In cases where suppliers/vendors are based in global locations and situations where a limited portfolio is marketed, a global partner with regional presence is useful to manage both business as usual activities as well as critical activities triggered by regional regulatory changes.
Global Market Expansion
Global market expansion is key to the corporate growth strategy for biopharma companies aiming at maximizing returns on their portfolio. This requires assessment of market opportunities coupled with regulatory pathways to identify shortest path to expand market presence in international markets. A regulatory strategy is a key input in the overall market growth plan that can help determine the cost, timelines and compliance requirements in upcoming markets. Starting from Regulatory intelligence, strategy to actual registration of products and life cycle maintenances, global market expansion necessitates engaging external experts and suppliers to build and implement regional strategy. A global market expansion plan will also include on-boarding new manufacturers and partners who need to be audited and thus a specialized regulatory partner in selected regions can also enable third party audits or mock audits to prepare for local health authority audits when needed.
In-Licensing/Out-Licensing
When acquiring new products and molecules, companies seek regulatory support both before making the licensing decision and post licensing deal. The pre-licensing regulatory support is sought in order to perform due diligence on the product/molecule including the dossier assessment, audits, smart drug profiling and other analysis along with the commercial, IP and clinical assessment. Depending on the expertise available inhouse and their bandwidth, companies chose to work with an external expert as independent consultant or a corporate partner. Post licensing activities include the regulatory strategy plan, the preparation of the dossier and the registration with health authorities. Once approved, all regulatory maintenance activities including review and implement labelling changes across products, variants and markets. Depending on the stage of the product (under development, marketed), relevant services are sought out.
Mergers and Acquisitions
Acquisitions and mergers are big milestones in a company’s journey. M&A scenarios create humungous regulatory burden both pre- and post-M&A. Pre-M&A includes regulatory due diligence of products in market, under development, suppliers, organization/departments, QMS and others to assess the current state and future state of the new organization. The scale and complexity of post-M&A activities are defined by the size of the organization, global presence, products under development and those marketed, shelved products, manufacturing sites, external suppliers, internal SOPs and other factors. Companies engage consulting organizations through the entire process pre-and post-M&A to develop the transition strategy and identify areas of operations as a result of M&A to work with potential regulatory outsourcing partners.
Divestment and Site Transfers
Divestment of manufacturing sites and site transfers due to change of manufacturers are significant change that has a larger regulatory impact. Ensuring new sites comply with already approved quality conditions right from drug substance, drug product quality, sterility, storage etc, engaging health authorities globally where products from the site are marketed and informing them about potential change is critical to success of such projects. Often depending on number of products and markets, the number of regulatory submissions and later changes on labelling and artworks, the regulatory activities can be overwhelming. Companies engage regulatory partners at strategic level for planning that helps them build a strong partnership that can manage the volume of activities while ensuring compliance.
Recalls and Safety Concerns
Quality concerns in batches, artworks/packaging, ingredients, safety concerns related to products in marketed products across markets lead companies to work with regulatory partners to enhance compliance using metrics based approach. In such scenarios, the focus on accountability on certain projects and outcomes is increased while working with a partners.
Financial and Market Drivers
As pharmaceutical products reach the patent cliff, the competition in the market for those products increase leading companies to identify strategies to reduce cost and stay competitive. Socio-economic and political conditions in countries around the world are dynamic and therefore organizations adapt different strategies. Working with suitable regulatory partner for both strategic and operational regulatory activities is part of the key strategy for organizations to navigate through such uncertainties.
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