Regulatory Strategy

MERAS provides tailored strategic guidance to achieve the best possible outcome by evaluating the different regulatory procedures available and how they apply to your product. Getting the right regulatory strategy from the beginning is the key to ensure optimum results and bringing your products to market.

Our experts besides having years of experience in the middle east and Africa region, they are constantly aware of all regulatory updates.

Meras Offers:

  • National requirements in Middle East and Africa
  • Advice on registration strategy: clinical, gap analysis, integrated product development planning , product positioning, selection of registration route, due diligence, target product profile, marketing authorization applications
  • Coordination and preparation of your marketing authorization application
  • Health authority meetings
  • Project planning and timeline as per the planned launch sequence

Regulatory has been the core of our business from the start, and over the years we’ve developed an experienced team who pride themselves in helping clients not only with strategy, but also with implementation, a key component to successful commercialization.

Our Strategic Services:

  • Actively consult with regulatory authorities for scientific advice (protocol assistance for orphan drugs)
  • Evaluate technical data to help determine the appropriate regulatory procedure and legal status of products
  • Arrange and manage scientific advice meetings with regulatory authorities
  • Propose optimal filing and submission strategies

Regulatory Management Services:

  • Clinical trial applications
  • Dossier preparation
  • Translation services
  • Submission processes
  • Liaison with health authorities
  • Marketing authorization applications, procedural management, and marketing authorization holder ship
  • Post-approval maintenance
  • Variations, renewals, pharmacovigilance, and PSURs
  • Technical expert services