Helping you define your regulatory campaign from early development to marketing authorization and beyond.
Our regulatory affairs consultants have a wealth of experience gained from working in both regulatory agencies and in-house, making them well-placed to offer a proactive and flexible solution that adapts to the needs and timelines of your project.
We can devise global regulatory strategies that combine both commercial goals and regulatory requirements and can assist with any regulatory project from CTD compilation to complex phase IV clinical trials, as well as CMC post-approval changes and management of global or local submissions, facilitated by our in-country team.
Ergomed’s regulatory affairs consultants are drawn from our senior team and include former agency regulators and assessors.
Our bespoke regulatory affairs consultancy service begins with an initial feasibility assessment to review the available data before developing a full proposal. A lead consultant and team of experts is assigned to craft a regulatory strategy detailing the supplementary data requirements, applicable governing regulations and program schedule to meet even the most demanding timelines.
Our regulatory affairs consultancy service covers:
- Regulatory strategy definition
- Gap analysis and due diligence assessments
- Scientific advice
- Orphan drug designation applications
- Clinical trial authorization (CTA) and investigational new drug (IND) filings
- Pediatric investigation plans, PIP / iPSP
- Fast track and breakthrough applications (FDA), PRIME (EMA)
- Marketing authorization (MAA) new drug applications (NDA), biologic license application (BLA), abbreviated new drug applications (ANDA)
- Launch and post-registration activities.