ATMP manufacturing service
There are different stages of medicine development process and this includes, good manufacturing practice (GMP), good clinical practice (GCP) and good laboratory practice (GLP) requirements. We offer a range of advisory services and incentives for FDA and EMA requirements to support the development of CGT.
Regulatory strategy & valuation process
• Assessment and guidance on all aspects of the regulatory strategy for product development.
• Supporting manufacturers in the development of ATMP, biologicals, small molecules, devices, biosimilars and combination products including MD simulation for patient safety.
• Advice on ATMP, Fast Track, breakthrough therapy, accelerated approval, and ANDA submissions.
Preparation and engagement of the EMA and FDA meetings
• Representing ATMP-Manufacturers in interactions and communications with the EMA and FDA.
• Preparing for EMA and FDA and counseling meetings.
• Review of submissions in EMA and FDA style.
• Advice on regulatory options and possible ways for regulatory strategies.
EMA and FDA filings
• Compose, review and publish original requests, changes and additions for ATMP products.
• Create or support the refinement of the regulatory strategy.
• Non-clinical development.
• Support for non-clinical pharmacology and toxicology for ATMP products and biologicals.
• Support in early development planning.
• GLP advice, supervision and compliance.
• Non-clinical program review and strategic support for EMA and FDA filings.
• Safety assessments for ATMP products, biologicals, small molecules, devices, biosimilars and combination products.
• Review of study protocols and reports for scientific performance and compliance with legal regulations.
• Clinical regulatory expertise for products in all phases of clinical development.
• Preparation of clinical trial applications.
• Clinical gap analysis, product development plans and value assessment process assessments.
• Development of the clinical protocol of phase 1-4.
• Review of clinical data in EMA and FDA style.
• Support of clinical studies for ATMP and biologicals.
• Planning clinical trials and monitoring trials conducted by CROs or individual investigators, including CRO selection and contract negotiation, tasks and schedules for clinical operations, selection of investigators / locations, on-site training, preparation / review of study documents, medical surveillance and DSMB organization.
• Regulatory, quality assurance and compliance services for ATMP products and biologicals.
• Quality-based production and development of analysis methods.
• Formulation development.
• Assessment and assessment of stability data and requirements.
• Preparation and review of applications for admission.
• Risk-based strategies for product development.
• Supervision of contractual services.
• Design, implement and upgrade manufacturing systems for a range of ATMP products, including small molecules, biologicals and biosimilars.
Transfer of ATMP products worldwide
• Transporting biological samples within 12 hours to all countries in the world.
• Providing solutions for the transportation under controlled conditions.
• GMP and GLP setup as well as GCP compliance.
• Gap assessments, PAI readiness.
• Audits program.
• Data checks (integrity and validation).
• Validation of computer systems (CSV) and compliance with part 11
In Vitro & Companion Diagnostics
• Competent technical instructions for in vitro diagnostic product development and regulation strategy, including accompanying diagnostics and personalized medical devices.
• Analytical and clinical study design and study management.
Building and managing od quality systems & training
• Support in the development of the documentation for the quality system, including expert technical reviews of the software development processes.
• Internal training on regulatory issues of the EMA and FDA and new policy developments.
Marketing of ATMP products
• Worldwide marketing strategies in different languages.
• Representing your company in the international ATMP-events.
Refinement of patient’s data
• Providing clear insights into the molecular pathology of a mutation through our following studies:
Functional annotation and enrichment analysis
• GO annotation
• GO enrichment
• Domain annotation
• COG annotation
• KOG annotation
• KEGG annotaion
• KEGG enrichment
• Subcellular localization
• Directed acylic graph (DAG)
• STEM analysis
• Hierarchal clustering
• K-means clustering
• Protein-Protein interaction analysis
• IPA analysis
• Co-expression network analysis
Protein sequence analysis
• Amino acid composition analysis
• Signal peptide prediction
• Protein motif prediction
• Ligand binding site prediction
• Transmembrane domain prediction
Protein structure analysis
• Homology modeling
• Molecular docking
• Molecular dynamic simulation
• Structure feature analysis
• Secondary structure analysis
Protein evolution analysis
• Sequence based analysis
• Structure based analysis
• Genome based analysis
Bioinformatics for metabolomics
Preprocess and normalization
• Fold change analysis
• T-test analysis
• Correlation analysis
• SAM service
• Volcano plot
• Heatmap service
• K-means service
• SOM service
Classification and feature selection
Quantitative Structure Activity Relationship (QSAR)