Chemistry Manufacturing Control (CMC) Consulting
Headquartered in Lugano, Switzerland, LEX Pharma Consulting aims at providing you with CMC support worldwide. Our firm specializes in all CMC matters, from drug discovery to post approval changes. Whether your company needs support for the definition of GMP starting materials, for the process validation strategy, for a technical transfer or for the preparation of a filing, we will be able to fully support you. We can also help you find the right CMO for the manufacturing of custom synthesis starting materials. We bring extensive experience and professionalism to every case and customize our support to your individual needs and concerns.
Our principles are Lean, Efficiency and eXcellence (LEX). We aim at providing you the best level of service keeping in mind efficiency and timelines.
Princesse Dell'Oca, founder of LEX Pharma Consulting, has been working in the pharmaceutical industry in various CMC roles for over a decade. She is updated on all the most recent developments of the pharma regulations and guidelines and she can count on a wide network of contacts across the world to support your business.
Get in touch with us to set up a consultation, or use the contact form at the bottom of this page to enquire whether our services are right for you.
Contact
☎ CONTACT
info@lexpharmaconsulting.com
+41(0)79 4180774
Areas of Expertise
cmc Regulatory
The pharma regulatory landscape is ever evolving on a country by country basis. With the consistent introduction of new country specific requirements, the complexity grows, and so does the risk of non-compliance and delays in the approval of the dossier. That’s where we come in.
Project Management
LEX Pharma Consulting is able to provide you with project management support for any kind of CMC project: from drug discovery to lifecycle management.
CMo/s Connection
LEX Pharma Consulting will help you find the best CMO to partner with you.
dossier Module 3 writing AND/OR revieW
We can write the dossier for you and/or provide you with a full review considering country specific requirements and guidelines.
Process Validation
We will support you defining the best validation strategy for your product considering regulatory requirements, volumes of production, launch timelines and target countries.
Overall regulatory support
In cooperation with other regulatory consultants experts in pre-clinical and clinical development, we can support you in the overall filing strategy definition, in the product development strategy and we can provide you with an overall dossier gap analysis.
TECHNOLOGY Transfer
Whether you need to transfer your production process from the development site to the commercial site or from one commercial site to another, we will be able to support you managing the whole project on your behalf and taking care of the documents required.
DUE DILIGENCE
LEX Pharma Consulting will support you in the due diligence process for the evaluation of products to be in-licensed. We will provide you with an overall CMC gap analysis including technical regulatory aspects.
“We must all obey the great law of change. It is the most powerful law of nature.”
Let's Chat.
Use the form below to contact us regarding your CMC/technical regulatory enquiry. Please be as detailed as possible. To help us best service your enquiry, we recommend that you first describe the issue you’re having before telling us what you want to achieve. You may also email or call us to make an appointment.
For job opportunities, please email us your resume. We’re always looking for new and exceptional talents.