Accelerating your journey with the best regulatory pathway

RLM Consulting provides strategic and operational regulatory affairs support for bio-pharma companies developing medicinal products, from early nonclinical development to the late phases of clinical development, in various therapeutic fields.

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Strategic Guidance

Our experienced staff provide strategic guidance to achieve the most appropriate regulatory scenario as well as practical feedback to drive the development of medicinal products.

Negotiating with authorities

We have extensive experience in negotiating with the EU national agencies, EMA and FDA. We act as an applicant for various procedures. 

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The 6 Stages

RLM provides regulatory support from early nonclinical development to the late phases of clinical development.

1

Discovery

Screening of molecule
Proof of concept
Full characterization
2

PRe-clinical

Pharmacology
Toxicology
3

clinical

Phase I
Phase II
Phase III
4

Registration

Preparation MAA
Submission
Preparation
Approval
5

LAunch

6

Post marketing

Pharmaco-vigilance
Phase IV
Variations