Areas of Practice
New Market Strategy
Regulatory Approvals
Sales Training
Pharmaceutical Development
Development of a pharmaceutical or aesthetic product is a huge investment in time and money. It is essential that you plan your program to optimise available technology, secure IP and maximise efficiencies in commercial manufacturing. Oakley Business Development can help you whether you are aiming to capitalise on the market opportunities presented in developing your own generics, finding the right dosage form and process for a NCE or developing a compelling presentation in the aesthetic or cosmetic market. From API through formulation development to submission and launch.
Commercial Manufacturing Tech Transfer and Process Scale-up
Selecting the best partner for your commercial manufacturing, whether part of a tech transfer or scaling up a new process, is essential for business success. Oakley Business Development can identify the most appropriate partner, create a development plan for the validation and commercialisation of your process, and ensure that you are generating the required data for regulatory compliance.
Licensing
Operational Due Diligence
Oakley Business Development utilises many decades of experience and a global network to identify targets for in-licencing to accelerate the growth of your business, or out-licencing maximising your long term ROI. Our expertise extends to advising on license agreements, revenue structuring and negotiation. We are happy working closely with your legal team or introducing you to world class experts appropriate to your business.
The Bio-Pharma/Aesthetic Market offers significant opportunities for business growth through expansion into new markets. Launching your business into a new market can be a complex process involving challenges in logistics, culture, and regulatory compliance of both product and business registration. Oakley Business Development has helped clients establish a base in new territories in the USA, Europe and Middle East and has advised and delivered solutions for regulatory approval, virtual office accommodation, distribution and legal and banking relationships
Oakley Business Development has been successful in a number of clients’ regulatory submissions, including; USFD ANDA and NDA, EMA MAA and MDR. Our experience lies within Module 3, or CMC matters and does not include clinical activities. Oakley is able to advise on the submission route, offer pre-submission readiness evaluation, and design pharmaceutical development projects specifically aimed to delivery the appropriate data set for submission and validation.
Drawing upon 40 years experience, and many millions of contracts won in business to business sales, Oakley can review and optimise your business development or sales process. Wether training new recruits, mentoring inexperienced management or optimising your existing systems
Oakley Business Development has the experience and expertise to support your evaluation of targets for acquisition, JV or licence deals. We can provide reporting on IP, operational capabilities and commercial robustness, whether your target is a technology, product or organisation.