Expert consulting services to help you streamline your drug development process and bring new treatments to market quickly and efficiently.
What does PharWise Research offer?
Expertise
Deep understanding of best practices across the full breadth of drug development.
Tailored Solutions
Customized solutions designed around your specific molecule, indication, and goals.
Flexibility
We accommodate short lead times and adapt to your changing needs as the program evolves.
In 3 Simple Steps
1
Set Up a Consultation
Get in touch to discuss your drug development needs and objectives.
2
Develop a Plan
We work with you to develop a tailored plan of action.
3
Execute the Plan
We execute the plan and ensure you meet your development goals.
Consulting Services
A complete toolkit for CMC and development, from first formulation to regulatory approval.
Formulation Development
Tailoring formulations to your unique needs
Developing a stable, effective formulation for your API can be complex. We bring a track record across a variety of APIs, including those hard to stabilize or solubilize, with a focus on phase-appropriate development, compliance, and robustness.
Pre-formulation — API characterization to select optimal components.
Dosage form selection — matched to API properties, indication, and market needs.
Comprehensive development — traditional and complex forms: semi-solids, suspensions, liquids, aerosols.
Lead optimization — performance, safety, shelf-life, and patient compliance.
Robustness — QbD principles to minimize formulation risk.
Process Development
Helping you scale up with confidence
Solving the complex challenges of process development and scale-up, from pilot phase through cGMP clinical manufacturing into commercialization, using QbD to de-risk scale-up and meet quality and regulatory standards.
Evaluation & optimization — troubleshooting to minimize production risk.
Documentation review — compliance review and gap analysis.
CMO selection & tech transfer — global network, efficient transfer.
Scale-up — pilot to commercial scale on time.
QbD de-risking — risk reduction and regulatory compliance.
CDMO Management
Partnering for seamless drug outsourcing
CDMO search and management to keep your clinical trials and production running smoothly, with a large network across drug substance and drug product manufacturers, plus technical consulting and project management.
Search & selection — the right CMO/CRO for clinical and commercial supply.
Contract negotiation — best terms on pricing, timelines, and quality.
Risk mitigation — supply chain, quality, and compliance.
Production planning — schedules, inventory, and timelines.
Regulatory CMC
Accelerating your product’s regulatory journey
A hands-on approach to regulatory submissions, authoring CMC documents and supporting regulatory meetings. Track record of timely submissions, successful FDA interactions, and NDA approvals across preclinical through post-approval.
Strategic planning — roadmap with timelines, budget, and expectations.
CMC gap analysis — remediation to avoid costly delays.
CMC documentation — prepared and reviewed for IND/NDA.
FDA interactions — Pre-IND, EOP2, and CMC questions.
Development Strategy
Tailored strategies to meet your goals
A clear strategy addresses the scientific, regulatory, and quality challenges of drug development. We analyze the landscape and focus on planning, risk management, and proactive decisions to bring your product to market.
Development plans — timelines, milestones, budgets, risk plan.
Project management — early stage through submission and approval.
Outsourcing strategy — successful execution at lower cost.
Supply chain — lower cost, less risk, on-time delivery.
Due diligence — in- and out-licensing support.
Quality by Design
A proactive approach to drug development
The FDA encourages QbD components in submissions. We help you understand and implement QbD while accelerating speed to market, launching safe, effective products reliably through a scientifically sound, compliant approach.
Risk assessments — product and process risk with mitigation.
QbD elements — defining CQAs, CMAs, and CPPs.
Design of Experiments — identifying critical parameters.
Knowledge & design space — ranges for consistent quality.
Control strategy — process controls and acceptance criteria.
