Case Studies
Summarised below are a number of case studies we feel reflect our areas of expertise. A more detailed review of each study is available via the links
Navigating Regulatory Complexity: A Case Study of a US Cosmetics Company's Acquisition and EU Market Entry Strategy for a Medical Device Portfolio
This case study highlights the regulatory challenges faced by a US cosmetics company that acquired a medical device portfolio for cosmetic use from an overseas manufacturer. Through the partnership with Oakley Business Development, the company successfully navigated the complex EU regulatory landscape by preparing a comprehensive technical package, conducting a safety study, and achieving CE registration. The study emphasizes the importance of meticulous compliance with EU regulations for medical devices marketed as cosmetics. It showcases the significance of engaging regulatory experts and employing strategic approaches to ensure successful market entry and expansion while maintaining compliance with stringent regulatory requirements.
Expanding Market Reach: Oakley's Acquisition and Successful Commercialization of Injectable Products
Oakley's strategic acquisition of a range of injectable products approved outside the USA exemplifies the company's ability to seize market opportunities and drive successful commercialization. By conducting a thorough dossier review, performing remedial work, and partnering with a US distribution partner, Oakley effectively navigated the regulatory landscape and positioned itself for success in the US market. This case study showcases Oakley's capabilities in acquisition, regulatory compliance, dossier remediation, and commercialization, underscoring their commitment to expanding market reach and maximizing the potential of acquired products.
Expanding Pharmaceutical Portfolio: Oakley's Successful Dossier Acquisition and Licensing in the GCC Region
Oakley Business Development's collaboration with the GCC-based client exemplifies their commitment to supporting market expansion and growth in the pharmaceutical industry. By identifying, negotiating, and licensing approved dossiers for regulatory filing within the GCC region, Oakley facilitated the client's successful market entry. The case study highlights Oakley's expertise in due diligence review, negotiation, and license agreement drafting, showcasing their ability to drive favorable outcomes for clients. This case study serves as a testament to Oakley's proficiency in dossier acquisition and licensing, fostering business growth and market success for pharmaceutical companies operating in the GCC region.
Driving Expansion into the US Market: Oakley's Collaboration with a European Pharma-Tech Company in Training and Mentoring the US Development Team
Oakley's collaboration with the European pharma-tech company in expanding into the US market exemplifies their expertise in training and mentoring, implementing sales processes, fostering cross-border relationships, and facilitating cultural integration. By training and
equipping the US development team, implementing sales processes and CRM systems, fostering productive relationships, and facilitating cultural transfer, Oakley played a pivotal role in driving the success of the expansion venture. The collaboration resulted in a seamless integration of the US operation into the company's overall strategy, enhancing productivity, and maintaining the company's values and culture throughout the expansion process.
A Strategic Partnership Driving Pharmaceutical Success: Oakley's Collaboration with a Virtual Pharmaceutical Company
The collaborative success between Oakley and the virtual pharmaceutical company serves as a testament to the importance of strategic partnerships in the pharmaceutical industry. Oakley's contribution, spanning formulation development, regulatory strategy, API supplier selection, CMC data management, process validation, and project management, was crucial in achieving FDA approval and a successful market launch. This case study underscores Oakley's proficiency in supporting virtual pharmaceutical companies throughout the entire product lifecycle, demonstrating their ability to navigate complexities, ensure regulatory compliance, and effectively manage post-approval supply.
Accelerating Product Development and Commercialization: Oakley's Collaboration with a Private Equity-Backed OTC Start-Up
Oakley's collaboration with the PE-based start-up exemplifies their ability to provide critical support and expertise in the pharmaceutical industry, particularly in expediting product development and commercialization. By assisting in initial formulation development, ensuring compliance with the OTC monograph, validating manufacturing processes, and executing a seamless technology transfer, Oakley successfully empowered the start-up to enter the market with their range of liquid remedies. This case study showcases Oakley's proficiency in supporting VC and PE-backed start-ups, demonstrating their commitment to driving innovation, regulatory compliance, and market success in the pharmaceutical industry.
Streamlining Tech Transfer and Ensuring Compliance: Oakley's Partnership with a US Company in Selecting a European Contract Manufacturer for Sterile Pre-filled Syringes
Oakley's collaboration with the US-based company in selecting a European contract manufacturer for sterile, pre-filled syringes exemplifies their expertise in seamless tech transfer, regulatory compliance, and cost negotiation. By efficiently planning and managing the tech transfer process, ensuring regulatory compliance, conducting a comprehensive compliance audit, and effectively negotiating cost-related aspects, Oakley successfully assisted the client in achieving a smooth transition while optimizing commercial production.
Driving Global Expansion: Oakley's Partnership with a Health and Beauty Product Company in Establishing New Markets
Oakley's collaboration with the Health and Beauty Product company in expanding its global reach into MENA and Europe showcases their expertise in market entry, regulatory compliance and strategic collaborations. By establishing regional offices, ensuring regulatory compliance, engaging distribution partners, PR organizations, and KOLs, Oakley played a vital role in driving the company's success in new markets. The collaboration resulted in an expanded global footprint, increased brand visibility, and accelerated growth for the Health and Beauty Product company.