STRATEGIC ASSESSMENT AND TACTICAL IMPLEMENTATION…..
Optimus Pharma Consulting provides its customers with data, information and insight(Business, Science, Regulations) to help shape product development plans: for pharmaceuticals, biologics, biosimilars, medical devices / combination products, fixed dose combinations, veterinary products, herbal products, food products etc.,. We then provide expert resources, time tested processes and methodology to help propel your products over early stage hurdles, past key milestones, and on to first-cycle approvals.
Integrating Science, Regulations and Measurable Business outcomes, combining local knowledge with global standards, our team moves beyond providing expert advise to get your project off the ground and moving at a fast pace.
Optimus developed and well tested implementation methodology – “ASIA” generates significant business gains on all implemented projects by ensuring, at each stage of project implementation lifecycle, a focus on impacts and results for both business and functional stakeholders. The business consulting approach and impeccable process implementation and delivery practices ensure that optimal business solutions are implemented to achieve specified business objectives, strategically. Integrated services we provide in this area include :
|<===== INTEGRATED PROGRAM DELIVERY =====>|
|Business Focus||Science Focus||Regulatory Focus|
|Portfolio Analysis||Scientific Advice||Regulatory Strategy & Advice|
|Market Assessment||Comprehensive Product Development Strategy and Plan||Regulatory and Clinical Trial Applications|
|Due Diligence, Gap Analysis – Candidate Selection||Development Planning: Preclinical through Launch||Regulatory Services to Fulfill Submission Requirements|
|Product Acquisition, Integration and Licensing Services||Comparative Effectiveness Strategy and Clinical Research||Submissions: NDA, ANDA, MAA, BLAs|
<=== Development Execution ===>
- Projects tracked in real time, delivered on schedule within service levels agreed upon – reducing development costs;
- Providing, localized strategic and process expertise to attain business competitiveness – delivering faster, quicker, approvable projects;
- Faster design, planning and implementation processes – leading to increased ROI;
- Improved regulatory compliance;
- Improved drug development productivity, risk mitigation, increased revenue.