"Getting timely regulatory approval can make or break a product launch."
Regulatory Filing | Drug Registration | Variations | Record Maintenance
How you benefit from our meticulous care in global regulatory filing:
“We provide comprehensive regulatory support for all projects and have particular expertise in Australia, New Zealand, Canada, Europe and USA.”
Anna Corke, Manager, Regulatory Affairs, Oceania & Americas
“Despite the stringent regulatory requirements in Europe, we consistently achieve approvals in 25% less time than the industry norm.”
Dr Rashmi Deshmukh, Manager, Regulatory Affairs, Europe & South Africa
What we do
Help you minimise delays and get quicker approvals for earlier market launches upon patent expiry.
CHALLENGE - The pharmaceutical industry is the second most regulated in the world (after aviation), and rightly so as it pertains to the health and well-being of the masses. Particularly in niche markets (where high barriers to entry guard highly lucrative rewards to be enjoyed by the best companies who can navigate the territory most successfully), how do we enable our multinational clients to stay ahead of the competition?
SOLUTION - Establish a strong regulatory team with people and systems in place on a global scale to share expertise from different backgrounds, and invite regulatory counsel at every stage of a project. Maintain great relationships, team camaraderie, and the enthusiasm to add value to all partnerships.
OUTCOME - Amazing turnaround time and expert collaboration; overcoming obstacles, innovating solutions, and delivery results that may prove too challenging for others. As such, our regulatory team actively contributes to our clients' on-going success by seizing opportunities more quickly and pre-empting any potential issues that may create delays and erode market dominance.