About the company

PLS is a global Regulatory Consultancy with expertise and capabilities to develop and deliver pragmatic solutions in the constantly changing frame-work of clinical development and post-marketing compliance.

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Regulatory solutions that are tailored for your asset

High quality dossier preparation and submission

Making Regulatory Science and Compliance easier

Broader capabilities, deeper expertise, better planning and regulatory collaboration

Our Expertise

Partum focuses on assessing the risks and developing solutions in order to support asset milestone decisions for the sponsors.

Partum operates by developing an ecosystem that suits the client needs to deliver regulatory solutions that are innovative, pragmatic and where applicable supported by precedents.
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Key Differentiators from Competitors

Hands-on Regulatory expertise with EMA, FDA, Health Canada, MHRA and and many other Regulatory Agencies

Fore-front regulatory planning aligned with product strategy and develop Regulatory Development Plan

Drafting and providing Sponsors' with Regulatory Risk Assessment at every milestone of drug development

Building Sponsors' relationship with Health-Authorities

Building clients
regulatory competence and training

View our service delivery model

VIEW OUR MODEL

Our professionals

Partum has successfully led Health Authority interactions and delivered tailored regulatory strategies, dossier preparation and submissions for the following:
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Pre-clinical evidence generation
First-in-Human and Phase 1 studies (Dose escalation and expansion)
MAA/BLA/NDA
IND/CTA submissions through all clinical stages
License maintenance activities

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