|
Business Development

Pacific-Link helps clients find new business development opportunities and expand their business including orphan drug designation and early product development.

PLC has extensive business development experience in Investigational New Drug (IND) strategy and management, New Drug Applications (NDA’s) and New Drug submissions (NDS for Canada) as well as finding compounds with potential transformative value that fit your company’s mission and clinical area of expertise.

Key Offerings for Business Development

 

Business Development support for Japan

Bridging Strategies for Japan to support partnering efforts

Due Diligence for acquiring and investing

 

Identify and contact potential partners and/or investors

Develop materials to present the client company

Develop strategies for entering new geographic markets

 

Regulatory assessment of drug licensing candidates

Risk assessment for drug licensing candidates (probability of approval and key risks)

Quality assessment of clinical, non-clinical and pharmaceutical data for accuracy and compliance with regulatory requirements

 

Quality assessment of companies

 

 

PLC’s overall strategy is to find the best fit for your company’s goals. Whether you are a small or medium-sized start-up biotech company looking to IPO or to sell a product, or an established large corporation filling your compound pipeline, PLC can deliver the expertise to evaluate your options and discover collaborative opportunities that create value. Our consultants have decades of experience in pharmaceuticals and understand the diverse and ever changing landscape of laws and regulations governing the United States, Japanese, Canadian and European markets. Our consultants are native to these territories and know how to navigate their systems. Our consultants have extensive connections with companies that operate in these areas that can lead to finding new compounds at various stages of proof of concept or established compounds with new potential clinical designations.

PLC also handles all clinical assessment and trials, including early phase and late stage, regulatory affairs, including IND, NDA/ANDA and PMA’s as well as safety management and analysis.