Regulatory Services

Regulatory hurdles can significantly can slow down your project, increase costs, and put your market entry at risk. Our expert team provides guidance and solutions to minimize product development time, accelerate product and agency approvals. Renejix regulatory specialists have prepared hundreds of submissions and are experienced in handling a wide range of therapeutic areas and project types (small molecules, NCEs, established dosage forms).

Customize regulatory affairs services for global markets and and receive support the full product lifecycle of your products. Receive support at every stage, either by reviewing submissions in coordination with your existing regulatory team or by full-service authoring and publishing.

Regulatory Compliance

Regulatory Compliance & Manufacturing:

Comprehensive Regulatory Understanding:

Renejix’s team of scientists and regulatory experts maintain an in-depth understanding of global pharmaceutical regulations, including those set by the FDA, EMA, MHRA, and PDMA.

Strategic Regulatory Planning:

Strategic planning is at the core of Renejix’s approach, ensuring that all phases of drug development and manufacturing align with current regulatory requirements.

Quality Assurance and Control:

Quality assurance and control are integral to Renejix’s operations, with rigorous systems in place to meet and exceed regulatory standards for every product.

Ensuring Product Integrity:

Regulatory manufacturing is critical in safeguarding product integrity, ensuring that each batch meets predefined quality criteria.

Adherence to Protocols:

It involves strict adherence to regulatory protocols and guidelines, such as GMP, to ensure consistent product quality and safety.

Surveillance and Adaptation:

Ongoing surveillance of regulatory changes and adaptation of manufacturing processes is vital to maintain compliance and market presence.

Proactive Approach:

Continuous Monitoring and Adaptation:

Renejix proactively monitors regulatory landscapes for changes and adapts processes accordingly to maintain compliance.

Risk Management:

Potential risks are identified and mitigated early in the development process, ensuring consistent quality and adherence to regulations.

Data Integrity and Documentation:

Renejix emphasizes the importance of data integrity and thorough documentation to demonstrate compliance during regulatory inspections.

Regulatory Affairs Expertise:

Regulatory Affairs Team:

The regulatory affairs team at Renejix is composed of seasoned professionals with extensive experience in navigating complex regulatory environments.

Training and Education:

Ongoing training and education programs are in place to keep the team abreast of the latest regulatory developments and best practices.

Patient Safety and Product Efficacy:

Renejix is committed to ensuring patient safety and product efficacy through compliance with regulatory guidelines.

Global Compliance:

With a global outlook, Renejix ensures that its products meet the regulatory requirements of all markets in which they are distributed.

Quality Assurance

Renejix’s Dedication to Quality Assurance:

Regulatory Excellence:

Upholding the highest standards of regulatory compliance, adhering to international guidelines from the FDA, EMA, MHRA, and PDMA.
Rigorous adherence to Good Manufacturing Practices (GMP) to ensure the safety, efficacy, and quality of pharmaceutical products.

Advanced Quality Management Systems:

State-of-the-art Quality Management Systems (QMS) that cover all aspects of production.
Innovative quality assurance techniques, such as real-time release testing and advanced analytical methods, to ensure product integrity.

Scientific Expertise:

Expert Team:

A team of scientists and engineers with extensive experience in the pharmaceutical industry, operating in FDA and cGMP-approved facilities.
Expertise across various aspects of drug development and manufacturing, ensuring excellence in every project.
Excellence in technical transfers, product launches, and the implementation of advanced manufacturing technologies.
Collaborating closely with pharmaceutical partners to develop customized strategies for each drug candidate.

Manufacturing Process

Renejix’s Manufacturing Process for Small Molecule Oral Dosage Forms:

Drug Discovery and Pre-formulation:

Initial identification of potent small molecule candidates through computational modeling and in vitro testing.
Assessment of physicochemical properties such as solubility, stability, and permeability to predict the molecule’s behavior in vivo.

Formulation Development:

Designing the formulation strategy to enhance the molecule’s bioavailability and stability.
Selection of appropriate excipients to support drug absorption and maintain product integrity throughout its shelf life.

Process Development:

Optimization of the manufacturing process, including granulation, blending, and tablet compression, to ensure scalability and reproducibility.
Implementation of Quality by Design (QbD) principles to build quality into the product from the outset.

Analytical Method Development:

Development and validation of analytical methods for quality control, ensuring the dosage form meets all regulatory requirements.
Utilization of advanced analytical technologies for real-time monitoring of critical quality attributes.

Quality Assurance and Control:

Comprehensive testing at every stage of production to ensure the final product meets all specifications.
Regular audits and reviews to maintain compliance with current Good Manufacturing Practices (cGMP).

Packaging and Distribution:

Use of innovative packaging solutions to protect the product from environmental factors and ensure patient compliance.
Efficient distribution systems to ensure timely delivery of the product to various markets.

Control Strategy

Our Advanced Control Strategy: This approach not only ensures the integrity of the drug product but also streamlines the path to market.

Quality Target Product Profile (QTPP):

Renejix begins by defining the QTPP, which outlines the necessary quality characteristics that the drug product should possess to deliver the therapeutic benefit.

Critical Quality Attributes (CQAs):

CQAs are identified based on the QTPP. These are the physical, chemical, biological, or microbiological properties that should be within an appropriate limit to ensure the desired product quality.

Risk Assessment:

A thorough risk assessment is conducted to understand the impact of potential variability in process parameters and material attributes on the CQAs.

Critical Process Parameters (CPPs):

CPPs are established, which are the key operational parameters affecting the production process that must be controlled to achieve the desired CQAs.

Control Strategy Implementation:

A robust control strategy is implemented, which includes control of the CPPs, in-process controls, and RTRT to ensure the CQAs are consistently met.

Real-Time Release Testing (RTRT):

RTRT Framework:

Renejix employs RTRT as a strategic part of their control strategy, allowing for the assessment of product quality in real-time during manufacturing.

Analytical Methods:

Validated analytical methods are utilized for RTRT, providing assurance of product quality based on process data, including material attributes and process controls.

Regulatory Alignment:

The RTRT approach is aligned with regulatory guidelines, ensuring that the release of each batch is based on sound scientific understanding and robust process control.

Process Analytical Testing (PAT):

PAT Integration:

PAT tools are integrated into the manufacturing process for real-time monitoring and control of the CPPs and CQAs.

Technology Utilization:

Advanced technologies such as near-infrared spectroscopy (NIR) and Raman spectroscopy are employed for continuous monitoring.

Data Analysis:

Data collected from PAT tools are analyzed using multivariate analysis to ensure the process remains within the designated control space.

Renejix CDMO’s Implementation Excellence:

Innovation in Manufacturing:

Renejix CDMO continuously innovates their manufacturing processes, integrating advanced analytical techniques and technologies to ensure the highest standards of product quality.

Expertise and Experience:

The team at Renejix CDMO comprises industry veterans with extensive experience in pharmaceutical manufacturing, ensuring that each project is executed with precision and care.

Customized Client Solutions:

Understanding that each client has unique needs, Renejix CDMO provides customized solutions that are flexible and scalable, ensuring successful outcomes for all projects.

Regulatory Compliance:

With a deep understanding of the global regulatory landscape, Renejix CDMO ensures that all products are compliant with the necessary guidelines and standards.

Validation And Verification

Process Validation and Verification:

Process Design and Development:

Scientific Foundation: Renejix’s process design is grounded in scientific understanding and product knowledge, ensuring robust development.
Design of Experiments (DoE): Utilization of DoE to understand the relationship between process parameters and product quality attributes.

Process Qualification:

Installation Qualification (IQ): Verification that equipment and facilities are installed correctly and meet specifications.
Operational Qualification (OQ): Ensuring that equipment operates within the intended range and consistently performs as expected.
Performance Qualification (PQ): Confirmation that the process, under anticipated conditions, consistently produces a product that meets all specifications and quality attributes.

Continued Process Verification:

Monitoring and Control: Ongoing assurance that the process remains in a state of control during routine production.
Data Trending: Analysis of production data to identify trends that might indicate a drift from process control.

Real-Time Release Testing (RTRT):

Method Validation: Renejix ensures that RTRT methods are fully validated for accuracy and reliability.
Quality Decisions: RTRT enables Renejix to make informed, real-time decisions about product quality during manufacturing.

Process Analytical Technology (PAT):

Implementation of PAT: Renejix integrates PAT tools to provide real-time data on critical process parameters and quality attributes.
Continuous Improvement: PAT data is used for continuous improvement, ensuring the process remains efficient and effective.

Renejix CDMO’s Commitment to Quality:

Regulatory Compliance: Renejix adheres to all relevant regulatory requirements, ensuring their processes meet global standards.
Risk Management: Proactive identification and mitigation of risks throughout the product lifecycle.
Quality Systems: Implementation of robust quality systems to ensure product quality and patient safety.

Expertise: A team of experienced professionals dedicated to maintaining the highest standards of pharmaceutical manufacturing.

End-To-End Solutions

End-to-End Manufacturing at Renejix CDMO:

Drug Substance Synthesis:

Innovative Synthesis: Development of novel synthetic routes for APIs, focusing on efficiency, yield, and environmental sustainability.
Process Intensification: Utilizing process intensification principles to enhance the synthesis process, reducing steps and solvent use.
Quality Control: Implementing stringent in-process controls to ensure the purity and quality of the API.

Drug Product Formulation:

Formulation Expertise: Crafting formulations that ensure the stability, efficacy, and patient acceptability of the drug product.
Dosage Form Optimization: Tailoring dosage forms to optimize delivery and therapeutic impact.
Excipient Compatibility: Ensuring compatibility and stability of all formulation components.

Seamless Process Integration:

Streamlined Transitions: Facilitating smooth transitions from API synthesis to drug product formulation.
Continuous Processing: Employing continuous processing to enhance efficiency and reduce production times.
Integrated Quality Assurance: Incorporating comprehensive quality assurance throughout the manufacturing process.

Analytical and Quality Control:

Advanced Analytics: Deploying state-of-the-art analytical techniques for in-depth product analysis.
Real-Time Monitoring: Utilizing real-time monitoring to ensure consistent product quality and compliance.
Regulatory Alignment: Ensuring all processes are aligned with current regulatory standards and guidelines.

Regulatory Compliance and Documentation:

Compliance Mastery: Mastery of regulatory requirements to ensure smooth approvals and market access.
Documentation Excellence: Maintaining impeccable documentation practices for all manufacturing processes.

Benefits

Utilizing Renejix as both your manufacturing and regulatory partner creates significant efficiencies, reducing time and error. Additional Renejix benefits include:

Strategic, global approach to regulatory planning and product development
Global network of regulatory affairs experts with local knowledge
Expertise in a wide range of therapeutic categories
Track record of success with regulatory approvals
Optimized compliance throughout the product lifecycle

Clinical Support & Labeling

Labeling assistance for clinical trial material (test and reference)
Regulatory label review for US, EU, Asia, Eastern Europe and Russia, Canada, Australia and New Zealand, Asia Pacific and Latin America
Translation and back-translation coordination

Dossier Authoring Services

Regulatory submission CMC writing including:

Investigational new drug applications (e.g., IND / INPD / CTA)
Marketing authorization applications (e.g., NDA / MAA / NDS)
Generic drug applications (e.g., ANDA / ANDS)
Drug Master Files
Global expansion filing support documents for ROW submissions
Lifecycle submissions such as variations (e.g., CBE-0 / CBE-30 / PAS / sANDS), annual reports, renewals

Regulatory Support & Advice

Define regulatory requirements and recommendations for new products, regulatory filing strategies, and post-approval changes:

Regulatory review of QbD (Quality by Design) / QbR (Question-based Review)
CMC Module 3 gap assessment (product development and existing dossiers)
CMC Module 3 pre-submission dossier review
Regulatory Publishing
Full publishing services available for FDA, EMA, and many other international Health Authorities
eCTD and non-eCTD electronic submissions (NeeS)
Paper to eCTD conversions
Collation and compilation of complete dossiers Module 1 through 5
Submission to Health Authorities via electronic gateways

Health Authority Meetings

Prepare correspondence documents and participate in pivotal meetings with health authorities for Renejix technology development projects across the product development timeline.