Why do you need Regulatory Intelligence & Strategy?
As we all know, regulatory intelligence involves a complex mix of processes that go beyond compliance. It needs a deep understanding of the current regulatory landscape, the key players, the stakeholders, the history of regulatory affairs and the main market influencers.
The criticality of regulatory intelligence and strategy lies in the fact that any change brought in at any stage of the product life-cycle from research to production can have a huge impact on compliance and adaptation as per current regulatory norms (which themselves are subject to changes by global health authorities), resource allocation, budgeting and manpower, all of which reflect on the overall business and profits, and can also make any business vulnerable. Not to mention the impact on patients’ safety. Hence one needs to be proactively on the lookout for any change in the regulatory and product development cycle to prevent any losses.
Large data needs to be analysed and put into perspective against the current regulatory norms keeping patient health as the ultimate aim. The legal implications and the geographical Byelaws also need to be taken utmost care of. The sheer multitude of data and legal complications pose potential risks which need to be mitigated. Only after analysing the political, practical, legal, civil, military (if any) and commercial implications, can one come to a reasoned strategy to regulate any product in the market. A robust regulatory intelligence strategy ensures seamless integration of the product in the market. Last but not least, regulatory intelligence – conducted in the early phases of norms’ evolution – allows the pharma industry to be able to shape the legislative panorama in collaboration with institutions, payors and patients’ associations.
How can PLG help you?
A team of skilled professionals across domains like market research, clinical and non-clinical development, regulatory submissions, special import permissions, legal, strategy, product launch, risk management, and government affairs help our clients with informed decision-making. Our on and off-shore resources provide knowledge and flexibility across geographies. PLG proactively leverages cross-domain intelligence with a holistic strategy to come up with a targeted, taxonomic approach – all this in a customized pattern tailored to client needs.
PLG’s multi-disciplinary team can help you with
- Market Intelligence across geographies
- Product Classification & Assessment
- Product Registration Norms
- Legal Compliance
- Regulatory Landscape Assessment
- Regulatory and Clinical Documentation
- Launch Strategy
- Cost-effectiveness Analysis
- Government Affairs
It must be noted that Regulatory Intelligence and Strategy comprise only a part of the overall picture. It needs to be effectively complemented with adequate documentation as per health authority mandates, appropriate quality and chemical manufacturing tests, safety and efficacy reports from clinical trials as well as competitive intelligence reports in other non-clinical aspects (legal, IT, administrative and technical aspects, logistics, etc.)
ensuring global reach
The number of variation packages PLG has prepared and written
The number of audits of dossiers PLG has carried out since 2017
The number of experts at your disposal for Regulatory Intelligence
Why choose PLG?
PLG harnesses the technical know-how for assessing and analysing the key issues within regulatory landscapes across 150 markets globally, either directly or through strategic partnerships with other organisations. PLG couples experience with innovation to come up with automated tools to aid in the validation of data and decision-making.
An organization is subject to handling multiple regulatory alerts daily. Our competent and proactive teams use both manual and automated methods to identify need gaps in the existing product landscape, mitigate all possible risks and manage these alerts. Such an approach ensures our capability to provide a holistic strategy for product development and its subsequent launch in the market.
Do you have a product in the making? Entrust PLG to analyse the market thoroughly and come up with a unique, one-stop solution for your business needs!