SOLUTIONS
Solution focused gap assessments begin each JPC project. The holistic approach evaluates the current state of the project and the immediate needs of the client.
Working together to find synergistic solutions addressing root problems and not symptoms of the problem provides value and expertise to support client programs at any stage of development.
Areas of Expertise
Compliance & Audits
Evaluation of Good Manufacturing Practices (GMP) using FDA regulatory guidance, ICH guidelines, and USP.
Regulatory Guidance
JPC assembles the guidances into actionable steps to prepare your product for FDA/EMA/Health Canada
- Evaluate your facility to go GMP
- Evaluate and implement FDA suggestions
- Design remediation and responses to 483s
FDA Meeting Preparation
JPC can help to ensure a meaningful outcome for your FDA meeting
- Review your records, including Documentation and Training Protocols
- Prepare your team for successful engagements with FDA representatives
- Review existing guidance with your team to prep questions before the meeting
Audits
Audits JPC Performs
- Vendor Qualification Audits
- For-Cause Audits
- Prior Approval Inspection Readiness Audits
We are able to perform both on-site and virtual audits, independently, or can accompany your subject matter experts (SMEs) and compliance staff.
As an outcome of audits, JPC provides an audit report with observations and recommendations for remediation.
Regulatory Affairs
Leveraging decades of experience to provide insight into how Regulators will critically evaluate submissions.
Experience
Decades of experience combine at JPC to provide exceptional regulatory affairs strategy and guidance.
Demonstrated track record of complete, concise, and accepted regulatory applications.
Writing Support
Accomplished writers with vast regulatory experience are available for comprehensive authoring and review.
A team capable of comprehensive regulatory writing services backed by decades of experience.
Regulatory Guidance
JPC leverages our experience to help clients understand how Regulators will critically evaluate their submission.
JPC Capabilities
- Transfers between INDs and IMPDs
- Writing support and reviews of submission documents, including Biologically Derived Materials (BLA) and New Drug Application (NDA) filings
- Ensure that the information presented to a regulator will be immediately interpretable and adequately explained to meet the regulator’s needs
- Spheres of Experience
- FDA
- Health Canada
- MAA Submissions to EMA
Chemistry Manufacturing & Controls
Supporting CMC needs related to manufacturing processes, quality controls, product specifications, and drug stability.
Process
Process
- Troubleshooting problems with the manufacturing process
- Reviewing Batch Records
- Assessing Viral Clearance for Biologics
Process Expertise:
- Protein Formulation
- Biologics Manufacturing
- Solid and Liquid Oral
- Dosage Forms
- Cell Therapies
- Gene Therapies
- Topicals
- Animal-derived Sterile Injectables
- Antibody Drug Conjugates
- New Chemical Entities/Small Molecules
Quality Control
- Evaluating and Optimizing Analytical Methods
- Reviewing Critical In Process Controls (IPC)
- Serving as Person in Plant (PIP) Representation
Technical Expertise
- Protein Chromatography
- Ultrafiltration Diaflitration (UFDF)
- HPLC
- Electrophoresis
- Potency Assays
- Virus Filtration
- Tableting
- Liquid Formulations
- ...and MORE!
Executive Consulting
Providing critical support and risk management to inform executive decision making
Due Dilligence
Evaluate prospective acquisitions
Review scientific and technology for the suitability of investment
Decision Making
JPC can facilitate decision-making by your executive team.
- Bridging the space between the scientific team and the executive group with a Big Picture focus on risk, probability of success, and profitability
- Communicating facts, risk, and options to top level decision makers by leveraging business acumen to interpret highly technical pharmaceutical, regulatory, and manufacturing information
- Business Development and support
Executive Project Managmenet
- Identifying all critical activities that need to be completed in sequence, and facilitating those activities with as little delay or disruption to the sequence as possible.
- Improving communication between internal stakeholders.
- JPC specializes in fostering collaboration between departments, streamlining communications, and ensuring that all relevant stakeholders are present.
- Maximizing the value of your company's existing staff to ensure the success of your project.
Third Party Relationship Management
Communicating with the Manufacturers who produce your Active Pharmaceutical Ingredients (API) and drug substance.
Working with your other vendors, including third-party logistics (3PL), packagers, facilities operational support.
JPC can assist with:
- Vendor Management
- Vendor Selection
- Reviewing Vendor Contracts
- Ensuring your project doesn’t get pushed to the back of the line
- Asking hard questions of your vendors to avoid groupthink
Training
Specialized and Tailored Training
Identify Training Gaps
JPC has a proven track record of identifying gaps in personnel expertise.
- Provide GMP Training to your staff
- Available to work with your staff to create custom-written, audio, or video trainings to improve employee skillsets or for onboarding new employees
Cross Functional Trainings
Introducing functional areas like Quality Control, Regulatory, and Manufacturing to think outside of their silos.
- Get QC to care about what the Regulatory people need
- Help the Regulatory staff understand what the Manufacturing people are doing
- Teach the CMC teams why the QC and Reg people need the things they are asking for
