Expertise.
Approval of ATMPs / biologics.
Master regulatory challenges in cell and gene therapies with a partner that combines experience, structure and depth.
Complex?
Are your active ingredients or therapies affected by complex requirements at EU or national level?
Innovative?
Do you work with cell, gene or tissue products for which there are no standard pathways?
Regulated?
Are your documents, studies and manufacturing processes prepared for a dialog-oriented and structured approval?
Strategic regulatory support for ATMPs and biologics.
The approval of ATMPs and biologics requires special strategies and early interaction with the authorities.
ATMPs (Advanced Therapy Medicinal Products) and biologics stand for medical innovation - but also for particularly high regulatory requirements. In addition to the centralized EU procedure and EMA classification, individual interactions with authorities, special procedures and intensive documentation requirements are often necessary.
We advise and support you throughout the entire approval process - from the classification request and scientific advice through to submission and follow-up. We take into account not only the regulatory basis, but also scientific, logistical and manufacturing-related aspects of your products.
With many years of experience in biotech approvals, we work with you to develop an optimal and process-oriented solution in terms of approval strategy - both nationally and at European level.
We accompany your approval of innovative biologics and ATMPs from strategy to successful submission.
Approval of biologics & ATMPs - Our services at a glance.
Our services cover all the key steps required to secure regulatory approval for ATMPs and biologics - at both national and European level.
Strategic Classification & Scientific Advice.
- ATMP classification and preparation for EMA classification procedure
- Support for scientific advice at national and EU level
- Analysis of approval paths (e.g. Conditional Approval, PRIME)
Dossier preparation & communication with authorities.
- Creation of CTD documents (modules 1-5)
- Coordination with manufacturing sites & CMC experts
- Interaction with authorities in the approval and amendment process
GMP & manufacturing concepts for biologics/ATMPs.
- Support in setting up and documenting manufacturing processes
- Development of control strategies and risk assessments
- Preparation for inspections and quality certificates
Case Studies - Successful approval strategies for biologics and ATMPs.
Three projects show how complex products were successfully led to approval through structured consulting.
EMA classification of a gene therapy drug
Approval of a recombinant biologic via centralized EU procedure
Approval of an ATMP manufacturing concept in the early phase
Challenge.
A start-up wanted to have a novel gene therapy correctly classified before clinical trials were submitted.Measures.
- Analysis of product characteristics and creation of a classification dossier
- Coordination with the EMA ATMP classification body
- Strategic preparation for the Scientific Advice procedure
Results.
- Successful ATMP classification by the EMA
- Clearly defined development and approval path
- Early integration of regulatory requirements
Success.
Strategic planning and avoidance of expensive detours in early development.Make complex approvals manageable - start with a customized ATMP strategy.
Your path to approval of innovative biologics & ATMPs.
We support biotech companies and ATMP developers from initial classification to market authorization - scientifically sound and regulatory reliable.
We check whether your product is classified as an ATMP or biologic, analyze the appropriate approval pathway (e.g. central, national, conditional approval) and create a strategy tailored to your pipeline.
We prepare you specifically for interactions with CAT, CHMP, EMA or national authorities - including orphan designation, PRIME status and PIP procedures. We coordinate briefing books, Q&A sessions and feedback closely with your team.
We create all modules of the eCTD - from module 1 to 5 - with a special focus on the CMC and clinical data requirements of highly complex products. We coordinate the submission process and accompany you through the review and response phases.
Biologics and ATMPs are subject to stringent requirements in terms of traceability, long-term safety and manufacturing control. We support you in the validation of your manufacturing processes, GMP planning and the implementation of technical control documents.
Our advice does not end with approval - we also provide support with lifecycle management, variation management, signal detection, vigilance concepts and post-approval commitments.
Prepare your innovative therapies safely for approval.
Related topics - Regulatory support at all levels.
These topics complement your regulatory strategy for ATMPs and biologics - from CMC documentation to communication with authorities.