Referral Management Service
When this generic international pharmaceutical company found its promising pan-European license application suddenly encountering an unexpected problem, it turned to ELC to navigate the complex referral process and get back on track to achieve the all-important approvals it needed to go to market.
Scientific Advice Service
When an Asia-based pharmaceutical company wanted to speed time-to-market for its generic to a leading brand-name drug, it engaged ELC Group to help to get the product successfully launched in European markets on its first submission – and as the first in its Market.
Complete Pharmacovigilance Solution
A generic pharmaceutical company looked to ELC Group’s experience and expert knowledge to help reduce operational costs, meet key regulatory deadlines and ensure continuing compliance across its global portfolio of products
Decentralised Procedures
Leading pharmaceutical company uses elc group to achieve marketing authorisation for a new cardiac treatment in multiple EU states
Mutual Recognition Procedures
Elc group helps leading pharmaceutical company to fast track EU marketing authorisation for a neurodegenerative disease drug
Biowaver submissions
Pharmaceutical company turns to elc group to navigate EU biowaver approvals for a new generic drug
CMC and Manufacturing Compliance
Leading global life sciences organization maintains GMP standards by outsourcing supplier audits to elc group
CMC and Manufacturing Compliance
elc group helps leading pharma company pass FDA inspection with flying colours