Pharmaceutical Development Project Checklist Template
Ensure regulatory compliance and accelerate your pharmaceutical development process. Our comprehensive checklist template guides you through critical milestones, from preclinical research to clinical trials and FDA submission. Streamline your project, reduce risks, and stay on track for success.
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Target Identification & Validation
Activities related to identifying and validating the disease target.
Initial Disease Area Selection Rationale
Disease Prevalence Data Source
Estimated Patient Population (Millions)
Unmet Medical Need Assessment Summary
Supporting Data Files (Market Research, Epidemiology)
Target Validation Approach
Date of Target Validation Milestone Completion
Drug Discovery
Focuses on identifying potential drug candidates.
Initial Target Hypothesis
Target Validation Method
Number of Initial Hit Compounds
Initial Screening Data Files
Screening Technologies Used
Date of Initial Hit Identification
Preclinical Development
Includes in vitro and in vivo studies to assess drug safety and efficacy.
Rationale for Preclinical Study Design
In Vitro Assay Raw Data
Maximum Tolerated Dose (MTD)
Start Date of In Vivo Toxicology Study
Animal Species Used in Toxicology Studies
Toxicology Endpoints Evaluated
Summary of Key Findings from Preclinical Studies
Formulation Development
Activities surrounding drug formulation and dosage form design.
Target Dosage (mg)
Dosage Form
Excipient Selection Rationale
Preliminary Formulation Data (e.g., solubility, stability)
Particle Size (µm)
Polymorphic Form
Formulation Optimization Completion Date
Clinical Trial Planning (Phase 1)
Planning and preparation for the first phase of clinical trials (safety).
Clinical Trial Protocol Summary
Protocol Approval Date
Planned Number of Participants
Primary Endpoint Measurement
Key Inclusion Criteria
First Patient Enrollment Planned Date
Investigator's Brochure (IB) Review & Updates
Clinical Trial Execution (Phase 1)
Execution and monitoring of Phase 1 clinical trials.
Patient Enrollment Start Date
First Patient Dosing Date
Number of Patients Enrolled
Adverse Event Reporting Summary (Phase 1)
Investigational Product Batch Number
Dosing Time (Example Patient)
Patient Consent Form (Sample)
Clinical Trial Planning (Phase 2)
Planning for Phase 2 trials (efficacy and dose-ranging).
Detailed Protocol Description
Planned Patient Enrollment Number
Planned Study Start Date
Estimated Study End Date
Primary Endpoint Measurement Method
Investigational Site Selection Criteria
Statistical Analysis Plan Review Status
Statistical Analysis Plan Document
Clinical Trial Execution (Phase 2)
Execution and monitoring of Phase 2 clinical trials.
Patient Enrollment Start Date
Patient Enrollment End Date
Number of Patients Enrolled
Summary of Adverse Events Reported
Data Monitoring Committee (DMC) Review Status
Data Quality Checks Completed?
Time of Critical Event (e.g., Serious Adverse Event)
Clinical Study Report Draft
Clinical Trial Planning (Phase 3)
Planning for Phase 3 trials (confirmatory efficacy).
Phase 3 Trial Protocol Summary
Planned Number of Participants
Primary Endpoint Measurement Method
Planned First Patient Enrollment Date
Estimated Trial Completion Date
Key Inclusion Criteria
Statistical Analysis Plan (SAP)
Clinical Trial Execution (Phase 3)
Execution and monitoring of Phase 3 clinical trials.
Trial Start Date
Number of Participants Enrolled
Summary of Protocol Deviations (if any)
Data Monitoring Committee (DMC) Review Status
Date of Last Safety Review
Key Findings from Interim Analysis (if applicable)
Interim Analysis Report (if applicable)
Investigational Product Accountability Status
Regulatory Submission (NDA/MAA)
Preparation and submission of the New Drug Application (NDA) or Marketing Authorization Application (MAA).
Summary of Clinical Data
Clinical Study Reports (CSRs)
Patient Enrollment Numbers
Submission Date
Regulatory Agency
Description of Manufacturing Process
CMC Data
Manufacturing Process Development & Validation
Development and validation of the manufacturing process for commercial production.
Process Flow Description
Critical Process Parameter (CPP) - Temperature (Celsius)
CPP - pH
Equipment Validation Status
Process Validation Protocol Document
Process Validation Start Date
Process Validation Completion Date
Critical Quality Attributes (CQA) Addressed
Post-Approval Activities & Phase 4 Trials
Activities following drug approval, including Phase 4 clinical trials and ongoing safety monitoring.
Phase 4 Trial Start Date
Summary of Post-Approval Safety Data
Number of Adverse Events Reported
Protocol Deviations Identified?
Supporting Documentation (e.g., Safety Reports)
Summary of Risk Management Plan Updates
Next Periodic Safety Update Report Due Date
Intellectual Property Management
Management of patents, trademarks, and other intellectual property related to the drug.
Patent Application Number(s)
Filing Date (Patent Application 1)
Filing Date (Patent Application 2)
Trademark Registration Number(s)
Patent Status (Application 1)
Number of Patent Claims
Summary of IP Strategy
Copies of Patent Documents
Project Management & Reporting
Overall project management activities and reporting to stakeholders.
Project Budget (Total)
Actual Spend to Date
Project Start Date
Projected Completion Date
Project Status
Key Risks & Mitigation Strategies
Project Dashboard Report
Reporting Frequency
Project Management Solution Screen Recording
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