global regulatory

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"Getting timely regulatory approval can make or break a product launch."

Global Regulatory  |  Success Stories

Get Quicker Regulatory Approval and Rigorous Follow-ups for Every Generic Drug Developed with Us

Regulatory Filing  |  Drug Registration  |  Variations  |  Record Maintenance

Bank on our country-specific regulatory experience to get things done right the first time.  

How you benefit from our meticulous care in global regulatory filing:

  • Increase success rate of approvals by leveraging our experience in submitting comprehensive dossiers
  • Pre-empt delays with our in-depth knowledge of each territory’s requirements and filing process
  • Maintain registrations in a timely manner as variations are introduced
  • Capitalise on our specific expertise in Australia, New Zealand, Canada, Europe (national submissions, de-centralised and mutual recognition) and in the USA
  • Leverage our regulatory expertise and comprehensive advisory resources

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.

  • Advise on approval requirements for different countries and enable you to meet them
  • Prepare dossiers that comply with international standards and the mandatory requirements of regulatory authorities
  • Save you time and effort: file and maintain records via electronic submission
  • Liaise with each country’s regulatory authority to obtain approval for drug registrations on your behalf
  • Help you maintain currency in your regulatory paperwork by handling regulatory submission updates

Success Stories

Regulatory expertise and experience clear hurdles in the race against time.

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.

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