Why a Focused Regulatory Consultancy Like Phortas Works Well for Pharma and Biotech

Admin
25 minutes ago
2 min read

For the last 7 years, we’ve helped drug companies get their products through regulatory agencies in the US, Europe, Japan, and beyond. CROs are great at running trials on a big scale, but when the real hurdle is the regulator, a specialist team like ours often moves things forward faster and with fewer headaches.

What We Do, Day to Day

Phortas only handles your regulatory work. That means:

Writing briefing packages and running practice sessions for FDA, EMA, or PMDA meetings.
Building full CTD or eCTD dossiers, Modules 1 to 5, with extra care on the summary sections and CMC parts.
Pushing for faster review tracks like breakthrough therapy e.g RMAT, PRIME
Keeping approved products on the market including label changes, renewals, pediatric plans, orphan status.

CROs are typically set up for site management, patient recruitment, monitoring, data management and biostats. Regulatory support is usually a side offering, focused only on clinical trial applications, so the depth on the latest agency thinking can be lighter.

People Who Stay With Your Program

Every Phortas lead has at least 15 years of experience working with FDA, EMA, PMDA, or another major national agency. Turnover is under 5 % a year. The person who plans your first IND is the same one who walks into the agency meeting with you. That continuity saves time and avoids repeated explanations.

How Phortas Bends to Fit Your Needs

We designed Phortas to adapt quickly:

Pick what you need – a single gap analysis, a mock panel, or full submission support. No long contracts unless you want them.
Work alongside your team or your CRO – we slot in where the bottleneck is, whether that’s a clinical-hold response or adcom prep.
Global but local– consultants in the US, EU, and Asia-Pacific, ready to jump on a call in your time zone and scale within days.
One asset or ten – startups with a single compound and mid-sized firms with parallel programs get the same attention.

Area	CRO Typical Setup	Phortas Approach
Scope of work	Bundled, multi-year	Modular, on-demand
Lead consultant	Rotates by project	Fixed for the program
Urgent agency request	Change-order process	24–48 hour start
Multi-country filings	Handled by regional units	Single strategy from the outset

One Quick Example

A cell-therapy client hit a clinical hold because the IND missed new FDA safety points on gene editing. Their CRO was still running the trial. We stepped in for four weeks, rewrote the preclinical section, filed the response in 12 days, and prepped the team for a Type A meeting. Hold lifted in under a month, trial kept rolling.