Your Partner to turn
innovative ideas
into approved products
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
What does PharWise Consulting offer?
In 3 Simple Steps
Consulting Services
include:
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
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.
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
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.
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.
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.
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.
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.
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.
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.
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.
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
Turning innovative ideas into
approved products.
Email Contact – contact@pharwise.com
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