Before a medicinal product can be placed on the market, it must demonstrate quality, efficacy and safety—and be granted a Marketing Authorization (MA) by a Regulatory Agency.

While efforts such as the Common Technical Document provide some guidance and consistency to global application procedures, the route to MA can still vary from country to county. Regulatory Agencies have the power to enforce requirements at a regional level—leading to local idiosyncrasies and unique challenges.

Once a drug receives MA, the license holder is also required to demonstrate CMC compliance and conduct on-going, post-marketing safety surveillance.

International experience. Local knowledge.

Obtaining and maintaining MAs is a highly detail-driven process that demands specialized expertise.

Our network of offices and partners offer the global reach and local depth to navigate regulatory challenges around the world.

Considering features such as active ingredient, proposed indication and regulatory history—we determine the best application route for your product. We manage every step of the procedure, and ensure all documentation is 100% accurate and compliant before submission.

Ready. Set. Green light.

From strategic CMC to statistical services, scientific writing to communication with Regulatory Agencies, risk management support to pre-approval inspections, our extensive list of services gets you to market faster and more efficiently.

Let us help you:

  • Determine the optimal submission roadmap for your product
  • Identify and respond to regional and local regulatory nuances
  • Establish meaningful collaborations with Regulatory Agencies
  • Control the quality and format of all data submitted
  • Simplify and standardize the publishing process with eSubmissions
  • Develop and maintain optimized product labeling
  • Create an integrated approach to market launch
  • Maintain compliance with ongoing pharmacovigilance requirements

Success Stories

PharmaLex has played a decisive role in the approval of many drugs sold around the world. Here are a few examples:

Helped a client apply for a MAA in both EU and US

with a gap analysis, corrective action plan, meeting support and templates for regulatory documentation.

Developed the EMA and FDA regulatory strategy

for a monoclonal antibody for the treatment of celiac disease.

Developed a global submission strategy

for a fixed dose combination product without EU & US reference markets.

Provided EU quality documentation

for a recombinant protein for veterinary use.

Let’s implement the best approval strategy for you

PharmaLex. Confidence beyond compliance.