Phase 2 trials are designed to rigorously evaluate the drug’s efficacy in treating the targeted medical condition. Unlike Phase 1 trials, which involve a small group of healthy volunteers, Phase  trials expand to include a larger cohort of subjects (often numbering in the hundreds). Researchers meticulously collect data on the drug’s effectiveness, safety profile, and potential side effects. This wealth of information informs subsequent decisions.

Late phase image - A scientist inspecting a manufacturing unit

Dose Confirmation

Phase 1 trials establish the initial dose range and safety parameters. In Phase 2, our focus shifts to confirming the optimal therapeutic dose. Our researchers iteratively refine the drug formulation based on insights gained from Phase 1 findings. We will maximize therapeutic benefit while minimizing adverse effects.


Phase 2 Manufacturing Considerations

 Formulation Refinement

  • Iterative Process: Armed with Phase 1 data, our scientists iteratively fine-tune the drug’s formulation by adjusting the composition, dosage form, and/or delivery method.

  • Stability and Bioavailability: Formulation refinements are geared toward enhancing stability (ensuring the drug remains effective over time) and bioavailability (ensuring optimal absorption in the body).

 Quality Assurance (QA)

  • cGMP Standards: Adherence to current Good Manufacturing Practices (cGMP) is non-negotiable. Our QA processes meticulously oversee each batch of the investigational drug, ensuring it meets stringent quality standards.

  • Batch-to-Batch Consistency: Consistency across multiple batches is critical. Our manufacturing protocols maintain uniform drug product quality throughout the trial.

Regulatory Guidance

FDA Recommendations

  • The U.S. Food and Drug Administration (FDA) provides specific guidelines for CMC (chemistry, manufacturing, and controls) information submitted during Phase 2 studies.

  • Documentation Precision: Detailed documentation on drug substance, drug product, and manufacturing processes is essential. We collaborate closely with regulatory experts to ensure compliance.

 ICH E6(R2) Emphasis: The International Council for Harmonisation (ICH) E6(R2) guideline underscores the importance of quality management and risk-based approaches in clinical trials. Our manufacturing practices align with these principles, emphasizing robust processes and risk mitigation.

Our Production Capabilities

Our state-of-the-art facilities empower us to handle diverse drug formulations. Here’s an expanded view of our production capabilities:

Tablet Manufacturing:

  • Direct Compression Tablets

  • Wet Granulated Tablets

  • Coating with Immediate Release and Modified Release Polymers: Tailoring drug     release profiles.

  • Tablets (mono and bi-layer) 

  • Fixed-dose combinations (FDCs)

  • Orally Disintegrating Tablets (ODTs)

  • Micro and Mini tablet

  • Aqueous film coated tablets


Capsule Manufacturing:

  • Hard and soft gelatin capsules

  • Delayed and extended-release capsules

  • Capsules for liquid, semi-solid, and solid fills

  • Capsules for dry powder inhalation (DPI)

  • Enteric-coated capsules

  • Capsules with beadlets or pellets for modified release

  • Capsules for reconstitution

  • Capsules with multiple-particulate fluid bead coating

  • Beads, including multi-particulate fluid bead coating

  • Stick packs

Oral Films Manufacturing 

Semi-Solid Dosage Manufacturing 

In Phase 2 we can manufacture semi-solid dosage forms for topical, transdermal, and oral applications.

  • Creams

  • Ointments

  • Emulsions

  • Aqueous and Non-Aqueous Based Gels

  • Pastes

Transdermal Patches Manufacturing


Oral Liquid and Syrup Manufacturing:

  • Aqueous and Non-Aqueous Based Liquids and Syrups

  • Wet and Dry Suspensions.

Nanoparticle and Lipid Nanoparticle (LNP) Manufacturing

Our advanced manufacturing services also extend to the production of nanoparticles and lipid nanoparticles, which are increasingly being used in drug delivery systems.

Nanoparticle Services:

  • Custom Formulations: We offer custom nanoparticle formulations, allowing for the encapsulation of a wide range of therapeutic agents.

  • Size Optimization: Our team can optimize the size of nanoparticles to enhance drug delivery and absorption.

  • Surface Modification: We provide surface modification services to improve the stability and bio-distribution of nanoparticle

In Phase 2 we focus on manufacturing nanoparticle dosage forms:


Lipid Nanoparticles

  • Nanostructured Lipid Carriers (NLC)

  • Solid Lipid Nanoparticles (SLN)

  • Liposomes

  • Nanoemulsions

  • Self-Nanoemulsifying Drug Delivery Systems (SNEDDS) 

  • Polymeric Nanoparticles

  • Nanocrystals


Our Services

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Here are some frequently asked questions about Late Phase

How does Renejix Pharma Solutions customize its CDMO services to meet the specific needs of Phase 2 clinical trials?

At Renejix Pharma Solutions, we recognize that Phase 2 trials are a pivotal step in confirming the therapeutic hypothesis established in Phase 1. Our customized services for Phase 2 trials are designed to address the increased complexity and higher stakes involved. We offer:

    • Tailored Formulation Development: Building on Phase 1 data, we refine formulations to improve efficacy, reduce side effects, and enhance patient compliance.
    • Adaptive Manufacturing Scale-Up: Transitioning from small-scale to mid-scale manufacturing, we maintain quality and consistency while allowing for flexibility in response to trial outcomes.
    • Strategic Regulatory Navigation: We provide comprehensive support in adapting regulatory strategies to meet the specific requirements of Phase 2 trials, including documentation and compliance strategies.
How does Renejix Pharma Solutions ensure seamless scalability from Phase 2 to Phase 3 manufacturing?

Our approach to ensuring seamless scalability includes:

    • Process Optimization: We continuously refine manufacturing processes to increase efficiency and reduce waste, ensuring a smooth transition to Phase 3 scale.
    • Tech Transfer Excellence: Employing best practices in technology transfer to maintain product quality as production volumes grow.
    • Proactive Capacity Planning: Expanding our facilities and capabilities in anticipation of the needs of Phase 3 trials.
    • Supply Chain Resilience: Strengthening supply chain logistics to handle the increased volume of trial materials without sacrificing quality or timelines.
Can Renejix Pharma Solutions provide comprehensive regulatory support during Phase 2?

Yes, comprehensive regulatory support is a cornerstone of our services, including:

    • Expert Guidance: Our regulatory experts provide up-to-date advice on compliance with FDA, EMA, and other international regulations.
    • Meticulous Documentation: Preparing detailed documentation to support regulatory submissions, including IND amendments and briefing packages.
    • Audit Preparedness: Maintaining a state of continuous audit readiness to facilitate inspections and reviews by regulatory authorities.
Does Renejix Pharma Solutions assist with protocol development and trial design for Phase 2?

Absolutely, our services extend to:

    • Trial Design Consultation: Collaborating with clients to develop scientifically sound and statistically robust trial designs.
    • Protocol Development: Crafting detailed protocols that meet regulatory standards and align with the therapeutic goals of the trial.
    • Endpoint Selection: Advising on the selection of appropriate clinical endpoints to ensure the trial objectives are met.
How does Renejix Pharma Solutions handle the analytical demands of Phase 2 trials?

Our analytical approach is rigorous and comprehensive, featuring:

    • Advanced Analytical Services: Providing extensive analytical testing, including bioanalytical assays, to support pharmacokinetics and pharmacodynamics studies.
    • Method Development and Validation: Developing and validating analytical methods suitable for the complexity of Phase 2 trials.
    • Quality Control Systems: Implementing robust quality control systems to ensure the integrity of trial materials throughout the trial duration.
What strategy does Renejix Pharma Solutions employ for managing multi-regional Phase 2 trials?

Our multi-regional trial management strategy includes:

    • Global Regulatory Insight: Understanding and navigating the regulatory nuances of different regions to ensure global trial compliance.
    • Logistical Coordination: Managing the complex logistics of distributing trial materials to various international sites.
    • Cultural Sensitivity: Addressing cultural differences in patient management and communication to enhance trial performance across regions.
How does Renejix Pharma Solutions contribute to the overall success and progression of Phase 2 clinical trials?

Our contribution to trial success includes:

    • Strategic Partnership: Acting as a strategic partner to our clients, providing insights and support that go beyond traditional CDMO roles.
    • Innovation in Drug Development: Applying innovative approaches to drug development challenges, enhancing the potential for successful trial outcomes.
    • Commitment to Excellence: Upholding a commitment to excellence in every aspect of our service, from manufacturing to regulatory support.
How does Renejix Pharma Solutions ensure the quality and consistency of drug products during Phase 3?

Quality and consistency are non-negotiable, and we ensure these through:

    • Advanced Quality Control Measures: Employing state-of-the-art quality control measures throughout the manufacturing process to ensure each batch meets the highest standards.
    • Process Validation: Conducting rigorous process validation to demonstrate the ability to produce drug products consistently meeting specifications.
    • Stability Testing: Performing extensive stability testing to ensure the drug product maintains its integrity throughout the trial and anticipated shelf life.
Can Renejix Pharma Solutions support the transition from Phase 3 to commercial production?

Yes, we are fully equipped to support the transition to commercial production by:

    • Commercial Scale-Up Expertise: Leveraging our expertise in scaling up processes to commercial levels without compromising product quality or efficacy.
    • Market Launch Preparation: Assisting with all aspects of market launch preparation, including packaging, labeling, and logistics.
    • Post-Market Surveillance Support: Providing post-market surveillance support to monitor the drug’s performance and safety in the general population.