What We Do
RLM supports clients with a range of services from regulatory strategy and expertise to trainings. We work across a range of product areas from small molecules and biologics to advanced therapy products.
Regulatory Strategy
RLM has dealt with very complex products and is confident in proposing effective development strategies in line with the EU and US guidelines. We work in close collaboration with our customers to gain the necessary understanding of their technology and adapt the strategy accordingly, making sure to request the Regulator’s input at critical stages of product development.
Our relationship with the EU national agencies, the EMA and FDA allows us to get rapid feed-back on questions raised by our customers.
RLM provides guidance on:
CMC requirements regarding the manufacturing, characterization, control and stability of the drug substance and drug product
Preclinical study protocols (proof of concept, pharmacokinetics, toxicology) required for the approval of different clinical phases.
RLM also acts as an applicant to the EU regulatory bodies. We deal directly with the FDA for INTERACT meeting requests and through our US partner for pre-IND and IND meetings, as well as for Orphan Drug Designations.
Product Expertise
The development of medicinal products uses an increasing number of therapeutic approaches, and the Regulatory Authorities must create new, or adapt existing, guidelines for the way to get them approved.
RLM Consulting acquired over the past 16 years a considerable expertise in RA guidance for the development of:
mRNA PRODUCTS
The Covid-19 pandemic has accelerated the mRNA medicinal products development. The technology being new, there is a limited regulatory framework and Sponsors are facing regulatory issues that we can help solving.
Synthetic peptides
Synthetic peptides are nowadays tested for the treatment of several pathologies, including for example the ones involving the nervous system and the autoimmunity.
MONOCLONAL ANTIBODIES (mAbs)
Monoclonal antibodies (mAbs) are produced as chimeric, humanized or recombinant human molecules; an increasing number of companies develop alternative ways to get them approved as biosimilars using alternative routes for which we have now a significant RA expertise.
Live Biotherapeutic Products (LBP)
With the evolving European and US Legislation on food supplements and medical devices, companies involved in probiotics are increasingly inclined to obtain medicinal product status. We gained a strong expertise in dialoguing with the EMA and national agencies to obtain approval for our customers of clinical trials with LBP’s.
Cell therapy approaches
Cell therapy approaches face complex regulatory challenges due to the complexity of the products. Over the past 13 years we have assisted over 20 small and medium sized enterprises (SME) in the development of their cell-based advanced therapy medicinal products.
Gene therapy (GT) medicinal products
Gene therapy (GT) medicinal products contain an active substance including a recombinant nucleic acid used in or administered to human beings with a view to regulating, repairing, replacing, adding, or deleting a genetic sequence. The numerous approaches of GT involve in most cases a need of specific inputs from the Medicine Agencies which we help our clients to obtain.
RLM has acquired particularly a high expertise with the investigational products based on genetically modified bacteria.
Writing of Regulatory documents
and submission
We have extensive experience in writing, submitting and negotiating different types of regulatory documents and procedures with the Authorities
Clinical Trial Applications (CTA)
We take care of the preparation, submission, and follow-up of CTA in all EU countries.
Investigational Medicinal Product Dossiers (IMPD) and Investigator Brochures (IB)
The key documents that are part of the packages submitted to the national Agencies for CTA.
Briefing documents
For scientific advice requests to the EMA or national competent authority.
For informal (INTERACT) and formal (Pre-IND, Type A and Type C) meetings with the FDA
Orphan Drug Designations and Rare Pediatric Disease Designations
Pediatric Investigation Plan (PIP)
Prime designation dossiers
Advanced Therapy Medicinal Product (ATMP) status request
Preparation of Viral Safety dossiers.
Writing of Biosafety dossiers for CTA and MAA involving genetically modified organisms (GMO).
For, Pre-IND, Type A, Type C and IND preparation and submission, we interact with the FDA through our US partner.
Due DILIGENCE
RLM Consulting can contribute to project due diligence:
Project investment assessment: audit and report on the capability of the company to develop a medicinal product along with the regulatory requirements.
Licensing-in of a novel product for which in-house expertise is not available. RLM can assess the product development stage, regulatory hurdles, additional work required, and the likely time to submission and approval of a marketing authorization application (MAA).
Due DILIGENCE
RLM Consulting can contribute
to project due diligence:
Project investment assessment: audit and report on the capability of the company to develop a medicinal product along with the regulatory requirements.
Licensing-in of a novel product for which in-house expertise is not available. RLM can assess the product development stage, regulatory hurdles, additional work required, and the likely time to submission and approval of a marketing authorization application (MAA).
Good Research Practice
RLM Consulting has developed a Quality System (“Good Research Practice” – GRP) to help small and medium size Enterprises (SME) to improve the organization and the reporting of their product development activities. Setting up the GRP involves an audit of the current R&D organization, writing of the required SOP and training of staff.
Trainings
RLM Consulting provides client-specific courses on most aspects of EU Regulatory affairs especially to support SMEs with insufficient in-house regulatory expertise or larger companies wanting to bring inexperienced staff up to the appropriate level of regulatory know-how. We also provide introductory courses to managers who deal with regulatory matters in product development teams.
