Regulatory Intelligence

MERAS provides regulatory intelligence that allows you to stay up to date with the dynamic and challenging regulatory environment in the Middle East and Africa region.

MERAS engages with clients throughout the product development and the registration process. This continuity of relationship builds trust and a deep understanding of the product and future strategy with the rollout to market.

MERAS also support you in understanding the significance of key regulatory documents and their potential impact on your product portfolio. This ensures an easy flow for drug approval process and medical devices registration. The challenges faced by healthcare companies operating in the Middle East and Africa region largely result from the lack of support or being unfamiliar with the regulatory environment in the target markets.

Nowadays, an increasing number of products must be characterized as borderline due to either innovative products that don’t fall under prospective regulations or overlaps in existing regulations.

Our regulatory intelligence services include:

  • Demarcation and identification of appropriate regulatory paths with applicable legislation
  • Development of optimized regulatory strategies aimed to achieve marketability
  • Intermediation and close interaction with competent authorities, notified bodies, and other regulatory bodies in order to safeguard chosen strategies

Behind what we offer at MERAS, we have highly capable, competent and experienced regulatory experts. Bringing together regulatory expertise from allover MEA region means that we can help our clients address the requirements of regulators, providers, payers and patients. This accelerates timelines, reduces risk of delays, and improves efficiency.

Our fields of expertise are