Pharmaceutical & Consumer Health
As a result of growing awareness for health issues and an increasing sense of self-care, the pharmaceutical and consumer healthcare industries are expected to continue being critical in the delivery of life saving solutions to patients.
Significant changes have been driven by the recent pandemic as it has shattered our world and changed nearly all aspects of our lives. It is slowly becoming a cliché to say that COVID-19 has catalyzed life sciences and healthcare trends – but nevertheless, it’s true. In a short time, the industry along with many others, has become much more dependent on technology to provide solutions managing data sciences and increasing efficiencies in processes.
- Shortening the health authority approval window
- Embracing digital-first business, patient engagement models and decentralized clinical trials
- Having greater resilience in planning, sourcing and performing of activities – especially during development
- Accelerating open collaborations, partnerships and M&As
- Re-thinking the leverage of data
- Conducting virtual audits
- Implementing measures to accelerate the process of taking financial risks
We offer global solutions covering the entire product lifecycle
Our solutions, consisting of core services, which are tailored to address each of your unique requirements. Extensive program management expertise is a key success factor within our service solutions.
Development and commercialization of pharmaceuticals
Today, the development and commercialization of pharmaceuticals is a highly complex undertaking, not only involving several distinct disciplines, work streams and procedures but often also covering multiple countries or regions. The economic success of pharmaceutical companies heavily depends on their ability to take the right decisions regarding their commercialization strategy, ultimately ensuring patient access to today’s therapies.
Holistic Planning and Management
During the development of a pharmaceutical product, irrelevant of whether it is a small or large molecule, there are many interfaces that require holistic planning and management.
In many cases, it is advisable to request input from health authorities in the form of Scientific Advice or Pre-Submission Meetings. Once the clinical development program has been established, Clinical Trial Applications including all required documentation (IB, IMPD/IND) and necessary correspondence with Health Authorities as well as Ethics Committees need to be managed, in a way that is consistent on a global scale and driven by scientific and economic considerations alike. Any specificities such as Orphan Designations, Adaptive Pathways and distinctions regarding pediatric patients (PIP, PSP) need to be factored in as early as possible to avoid any negative impact on development timelines and costs.
Planning, preparation and submission
The next milestone is the planning, preparation and submission of the application dossier in all targeted jurisdictions. From a business perspective NDAs, BLAs and MAAs are best prepared using a maximum of synergies which, again, requires smart and holistic planning well ahead of starting the actual work. An aspect easily neglected until the 11th hour is the compilation, e-readiness and publishing of a fully compliant eCTD through the appropriate electronic gateways and platforms. Underestimation of these final steps in a pharmaceutical submission often leads to missing internal or external deadlines associated with delays in market access.
Retain Marketing Authorization
After a medicinal product has obtained Marketing Authority (MA,) it is authorized for commercial use with all the necessary tasks associated with a successful life cycle maintenance to ensure product compliance, including variations, renewals, pharmacovigilance, and GxP duties and potential line extensions and globalization efforts. To retain Marketing Authorization and ensure compliant access to pharmaceuticals, the MA holder must continually:
- Update work to ensure the approved dossier is valid
- Address safety surveillance issues by having pharmacovigilance systems in place
- Implement and maintain quality management / assurance systems to deal with developments such as changes in the manufacturing of the product and relevant changes in the company’s settings
- Respond to renewal requirements, as necessary
PharmaLex is one of the largest global specialized providers for the life science industry. We work holistically with our clients to combine intelligent global and regional strategies with operational excellence that delivers effectively.
We are large enough to scale and manage all client programs, but small enough to adapt to client needs. PharmaLex prides itself on becoming an extension of our client’s team; with the quick turnaround, dedicated expertise, and flexibility needed to support the market and patient access to needed pharmaceuticals.
For the pharmaceutical industry to keep up with patients’ expectations some of these changes will need to continue and even develop further to ensure the availability of safe medicinal products to patients when they need them.
With new players entering the market and digitalization on the rise, consumer health companies are looking for a trusted partner to help guide them through the rapidly changing regulatory environment and adapt to the new trend of health consciousness.
The PharmaLex team offers a wide set of capabilities to help you adapt fast to changing expectations, leading the way to improve patient health now and in the future.
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