PharWise Consulting

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Your Partner to turn
innovative ideas
into approved products

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Navigating the Complexities of
Drug Development

Get expert consulting services to help you streamline your drug development
process and bring new treatments to market quickly and efficiently

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What does PharWise Consulting offer?

Expertise

Deep understanding of best practices associated with drug development

Tailored Solutions

Customized solution to meet your specific needs

Flexibility

We accommodate short lead times and adapt to your changing needs

In 3 Simple Steps

Set Up A Consultation

Get in touch to discuss your drug development needs and objectives

Develop A Plan

We will work with you to develop a tailored plan of action

Execute Plan

We will execute the plan and ensure you meet your development goals

 

 

Consulting Services

include:

<b>Formulation</b> Development

Formulation Development

Tailoring Formulations to Your Unique Needs.

<b>Process</b> Development

Process Development

Helping You Scale Up with Confidence.

<b>CDMO</b> Management

CDMO Management

Partnering for Seamless Drug Outsourcing.

<b>Regulatory</b> CMC

Regulatory CMC

Customized Support to Accelerate your Products Regulatory Journey.

<b>Development</b> Strategy

Development Strategy

Tailored strategies to meet your development goals.

<b>Quality</b> By Design

Quality By Design

A Proactive Approach to Drug Development.

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Formulation Development Logo

Formulation Development

Developing a stable and effective formulation for your API can be a complex task

Track record in the formulation development of a variety of APIs, including those that are challenging to stabilize or solubilize.

Focus on Phase appropriate development, regulatory compliance and robustness

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Formulation Development Services:

  • Pre-formulation
    Expertise in understanding API characteristics and interactions to select the optimal formulation components.
  • Dosage Form Selection
    Dosage form evaluation and selection, based on API properties, indication, and market needs, to optimize therapeutic efficacy and patient compliance.
  • Comprehensive Formulation development
    Traditional and complex dosage forms. Specialization in the formulation of hard-to-stabilize or solubilize drugs, including semi-solids, suspensions, liquids, and aerosols.
  • Lead Optimization & Candidate Selection
    Aiming to reach optimal performance, safety, shelf-life and patient compliance.
  • Formulation Robustness
    Expertise in QbD principles to minimize formulation risks and ensure regulatory compliance.

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process

Process Development

Specializing in solving the complex challenges of process development and scale up

Extensive experience in scaling up production from the pilot phase, through cGMP clinical trial manufacturing, and into commercialization.

Using Quality by Design (QbD) principles to de risk the scale up process and ensure that your product meets both quality and regulatory standards

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Process Development Services:

  • Process evaluation, adaptation, and optimization
    Process troubleshooting and optimization. Identification and resolution of process issues to minimize production risks and optimize product quality.
  • Manufacturing documentation reviews
    Regulatory compliance review and gap analysis of manufacturing documentation.
  • CMO selection and technology transfers
    Global CMO network. Expertise in technology transfer to CMOs for efficient and successful manufacturing scale-up.
  • Scale-up to clinical scale and commercial scale
    Efficient scaling up from pilot to commercial scale to meet production demands and timelines.
  • QbD principles to de-risk the scale-up process
    Expertise in QbD principles for efficient and effective manufacturing scale-up, risk reduction, and regulatory compliance.

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process
cdmo
CDMO Management Logo

CDMO Management

CDMO search and management services are designed to ensure that your clinical trials and production run smoothly.

Strong experience in identifying the appropriate CDMOs for your specific needs, large network both in drug substance and drug product manufacturers.

Technical consulting along with project management support for selection and management of outsourcing partners for drug substances and drug products.

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CDMO Management Services:

  • CMDO search and selection
    Identification, selection, and management of contract manufacturing and quality testing sites (CMO/CRO) for clinical and commercial drug substance/drug product.
  • Contract Negotiation
    Support for contract and MSA negotiation to ensure that you get the best possible terms from your CDMOs, including pricing, timelines, and quality expectations.
  • Ongoing CDMO management services
    End-to-end CMC project management support. Focus on collaborative approach for effective communication and timely decision-making to keep your project on track.
  • Risk Mitigation
    Identify and mitigate potential risks associated with outsourcing your drug development activities, including supply chain, quality and compliance risks.
  • Production Planning
    Detailed planning to optimize production schedules, prevent supply chain disruptions, manage inventory levels and meet your development timelines.

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regulatory

Regulatory CMC

A hands on approach to regulatory submissions, including authoring of CMC regulatory documents and support in regulatory meetings.

Track record of timely regulatory submissions, successful FDA interactions, and NDA approvals.

Comprehensive understanding of CMC development from preclinical to post approval stages, including development of QbD packages, pharmaceutical development reports and control strategies.

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Regulatory CMC Services:

  • Strategic Planning
    Working with you to develop a high-level roadmap for your project, with timelines, budget estimates and regulatory expectations.
  • CMC gap analysis
    Identify and address gaps in CMC development, with remediation plans to ensure compliance and avoid costly delays.
  • CMC Documentation
    Assistance with the preparation and review of CMC documentation for submission in your IND or NDA.
  • FDA Interactions
    Support for FDA interactions, including Pre-IND and EOP2 meetings, and addressing CMC questions.

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regulatory
strategy
Strategy Logo

Development Strategy

Clear development strategy helps address the unique challenges of drug development, from scientific, regulatory, and quality perspectives.

Comprehensive analysis of the scientific and regulatory landscape, to help you achieve an effective and efficient development plan.

With a focus on strategic planning, risk management, and proactive decision making, our development strategy services can help you navigate the complex drug development landscape and achieve success in bringing your product to market.

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Development Strategy Services:

  • Development Plan Creation
    Creation of a comprehensive development plans that includes timelines (Gantt chart), milestones, budgets, and a risk management plan.
  • Project Management
    Coordinating all aspects from early-stage development to regulatory submission and approval, with clear communication and collaboration between all stakeholders.
  • Outsourcing Strategy
    Develop an outsourcing strategy for key development activities to ensure successful execution and reduce costs.
  • Supply chain optimization
    Evaluate and optimize your supply chain to reduce costs, mitigate risks, and ensure timely delivery of materials and products.
  • Due Diligence Support
    Provide due diligence support for your in-licensing and out-licensing opportunities.

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qbd

Quality By Design

The FDA now encourages and looks for QbD components in regulatory submissions.

We can help you not only understand and implement QbD , but also accelerate speed to market, launching valuable, safe, and effective drug products in a reliable and cost efficient manner.

Bring your products to market with a scientifically sound and regulatory compliant approach, through our Quality by Design (QbD) platform.

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Quality By Design Services:

  • Technical Risk assessments
    Comprehensive assessments of your product and process risks, development of mitigation strategies to ensure the highest level of quality and compliance
  • Defining QbD Elements
    Identifying the critical quality attributes (CQAs), critical material attributes (CMAs) and critical process parameters (CPPs) for your product, establishing a solid foundation for QbD program development.
  • Design of Experiments
    Study design and statistical analysis of experiments to identify critical material and process parameters and their effects on product quality
  • Knowledge & Design Space
    Gaining more understanding of your product and defining ranges able to consistently produce the desired product quality.
  • Control Strategy Development
    Developing robust control strategies, including process controls, in-process testing, and acceptance criteria, to ensure product quality and consistency

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qbd
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Turning innovative ideas into
approved products.

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