The global pharmaceutical industry has long been known for its unpredictability. Returns on investment from research efforts are volatile, and the interpretation of regulations often add to the uncertainties of this sector. Still, it would be difficult to find a period in the past when pharmaceutical companies faced a more challenging and disruptive time than they are experiencing now, a time when drug companies have no choice but to reevaluate their business model to survive, including building regulatory capabilities and compliance to succeed in a VUCA ( Volatile, Uncertain, Complex & Ambiguous) World.
The pharmaceutical industry has for long operated through “Functional Silos” that separates R&D, commercial, production, and supply chain domains. These Silos delay patient access by increasing inefficiency and duplicating resource utilization. Thereby affecting quality and speedy approval timelines, influencing pricing, and impacting the launch of niche innovative therapeutics by the biopharma industry, impacting business value outcomes.
Thus, the time is now for the Biopharma and Life Sciences Companies to adapt their operating models in a way that brings all of these interdependent functions together. Shenaz and Zaki founded PharmaLeaf (ICH language -electronic regulatory data) with the belief that regulatory strategy and compliant processes were the cornerstones in the product life cycle from drug discovery to market access.
In the past 12 years, PharmaLeaf is duly recognized as a home grown, virtual, global Bio Pharma Company offering domain specific techno-commercial expertise, differentiated by Regulatory Affairs and GxP Compliance, “Advancing Global Access” to innovative therapeutics and healthcare products across lifecycle management. Their clients range from start-ups, mid-cap generic players to global organizations and big pharma.
The Dynamic Duo is Passionate about Healthcare
Dr. Shenaz Khaleeli, a “Global Regulator Practitioner” (GRP) with over 3 decades of techno- commercial knowledge and industry experience, coupled with business skills and a collaborative approach has successfully demonstrated the value, that a GRP brings to the table i.e. connects the cross-functional cohesive team bringing innovative products and hope to the patients. With a PhD in Pharmacology and M. Pharm in Pharmaceutics, Dr. Shenaz has extensive Pharma & Healthcare experience within MNCs, Generics, and Life Science Companies.
As Co-founder and Technical Service Director at PharmaLeaf, she leads a talented and enthusiastic team with a wide bandwidth of expertise, coupled with hands on experience across products i.e. biological, chemical, herbal, devices etc., markets i.e. regulated & emerging and domains i.e. clinical, CMC & business to provide a consolidated, integrated, end to end service across regulatory, compliance and project management throughout development and commercialization.
Mohammed Zaki Khaleeli is the Cofounder and Business Service Director at PharmaLeaf and a serial entrepreneur, DBA and BSc with over 4 decades of domestic and international business experience across pharma, chemicals, home products, hospitality and realty. Zaki’s forte is strategic business planning evaluation, development and execution of new revenue streams. He is responsible for executing collaborative business contracts with Associates that are strategically located across geographies, complementing PharmaLeaf’s reach and successful endeavors till date in Asia/ASEAN, Middle East/GCC and supporting Europe/UK, North America, Canada and Australia/NZ.
Shenaz and Zaki, strongly believed in the vision that “regulatory capability” would evolve as a Science and Art, to become a strategic function in the near future, driving business value outcomes, within a highly regulated and dynamic global bio-pharma and healthcare industry.
Towards this endeavor, they are committed to nurture GRPs through their dedicated regulatory academy “PCRA”, focusing on knowledge, skills and behaviors required to succeed in a collaborative environment.
Furthermore, ZUN Foundation, the CSR initiative, complements their vision, by promoting healthcare awareness to the public on options available for quality, safe and cost effective medicines.
Innovative Services Responding to Diverse Customer Needs
PharmaLeaf is much more than a regulatory and compliance consultancy. Being a virtual biopharma company, their in-house team supported by an extensive network of Domain-Subject Matter Experts (SME) across products & markets scope the project requirements for each phase, including regulatory classification, filing strategy and risk assessment to prepare a customized plan with techno –commercial deliverables, budgets and timelines
Their track record demonstrates that clients accomplish more when collaborating with a trustworthy partner like PharmaLeaf by leveraging synergies and successfully executing challenging projects. Domain experts share best global industry practice, experience and learning, to instill confidence and earn the client’s trust, bringing innovative products with competitive label claim to the markets and thereafter support post-approval compliance. PharmaLeaf also conducts diligence exercises, facilitating in and out licensing arrangements to support mergers and transfers of licenses.
PharmaLeaf continues to be recognized for finding “creative solutions” that are “delivery driven.” The differentiation arises from their capability to think out-of-the-box and human capital continuity ensures cost effective and lean processes facilitating time to market. They take pride in their team’s techno-commercial expertise and relevant industry experience, leveraged by expertise in Regulatory Affairs, Quality Assurance and Project Management.
PharmaLeaf’s Business Model is “Referral Driven.” Project Performance Metrics include level of technical & regulatory competence, nature of queries from agencies, turnaround timelines for milestones, resource utilization, and positive feedback on client’s experience with quality –speedy approvals resulting in new project enquiries and referrals from their network.
Upcoming Developments with Future Business Drivers
Shenaz predicts the continued convergence and harmonization of regulations across developed and emerging markets, creating opportunities for techno-commercial teams connected by GRP to register and market innovative products simultaneously across the world. PharmaLeaf aims to leverage technology and utilize “real time regulatory data” to drive efficiencies and enable global reach.
PharmaLeaf: An Integrated Global Regulatory Organization Driving Business Value Outcomes
