One system of work,shaped to each team.

Tech Transfer

Tech Transfer Charter Generator

~20–35 hrs per TTC document

Process Development

Process Development Plan Author

~25–45 hrs per PDP document

Analytical Development

Analytical Development Plan Author

~20–35 hrs per ADP document

Tech Transfer

MSAT Execution Plan Author

~25-40 hrs per MEP document

Tech Transfer

MSAT Execution Summary Author

~20–35 hrs per MES document

Tech Transfer

Analytical Transfer Summary Author

~15–25 hrs per ATS document

Tech Transfer

Scale-Down Model Qualification Protocol Author

~20–35 hrs per SDMQ Protocol

CQV

Process Validation Protocol Author

~20–35 hrs per PVP document

CQV

Continued Process Verification Summary Author

~20–35 hrs per CPVS document

Analytical Development

Analytical Validation Summary Author

Substantial hours saved per Analytical Validation Summary versus manual authoring

Tech Transfer

Comparability Report Author

~20–35 hrs per CR document

Quality Records

Quality Risk Assessment (QRM / FMEA, ICH Q9)

15–30 hours across SMEs — convening workshops, building FMEA tables by hand, and normalizing scores.

Quality Records

Site Master File (SMF)

Days to weeks across QA / Regulatory — compiling nine chapters by hand, chasing current site data, retyping tables, and re-checking against the PIC/S format.

Supply Chain

Aseptic Process Simulation (Media Fill)

15–30 hours across MSAT and QA — building worst-case rationale, intervention matrices, and acceptance tables by hand.

Analytical Development

Stability Study

Days of manual table-building, trend analysis, and formatting per report.

Analytical Development

Viral Safety / Adventitious Agent Assessment

Days to weeks across virology and QA — collating cell-bank, testing, and clearance data by hand, reconciling LRVs against criteria, and re-checking against Q5A(R2).

Supply Chain

Supplier Qualification

20–40 hours of supplier-quality time gathering evidence, mapping it to criteria, and formatting the assessment by hand.

Supply Chain

Clinical / IMP Supply Plan

30–60 hours across clinical supply and QA building demand models, coverage tables, and distribution plans by hand.

Tech Transfer

Tech Transfer Charter Generator

~20–35 hrs per TTC document

Process Development

Process Development Plan Author

~25–45 hrs per PDP document

Analytical Development

Analytical Development Plan Author

~20–35 hrs per ADP document

Tech Transfer

MSAT Execution Plan Author

~25-40 hrs per MEP document

Tech Transfer

MSAT Execution Summary Author

~20–35 hrs per MES document

Tech Transfer

Analytical Transfer Summary Author

~15–25 hrs per ATS document

Tech Transfer

Scale-Down Model Qualification Protocol Author

~20–35 hrs per SDMQ Protocol

CQV

Process Validation Protocol Author

~20–35 hrs per PVP document

CQV

Continued Process Verification Summary Author

~20–35 hrs per CPVS document

Analytical Development

Analytical Validation Summary Author

Substantial hours saved per Analytical Validation Summary versus manual authoring

Tech Transfer

Comparability Report Author

~20–35 hrs per CR document

Quality Records

Quality Risk Assessment (QRM / FMEA, ICH Q9)

15–30 hours across SMEs — convening workshops, building FMEA tables by hand, and normalizing scores.

Quality Records

Site Master File (SMF)

Days to weeks across QA / Regulatory — compiling nine chapters by hand, chasing current site data, retyping tables, and re-checking against the PIC/S format.

Supply Chain

Aseptic Process Simulation (Media Fill)

15–30 hours across MSAT and QA — building worst-case rationale, intervention matrices, and acceptance tables by hand.

Analytical Development

Stability Study

Days of manual table-building, trend analysis, and formatting per report.

Analytical Development

Viral Safety / Adventitious Agent Assessment

Days to weeks across virology and QA — collating cell-bank, testing, and clearance data by hand, reconciling LRVs against criteria, and re-checking against Q5A(R2).

Supply Chain

Supplier Qualification

20–40 hours of supplier-quality time gathering evidence, mapping it to criteria, and formatting the assessment by hand.

Supply Chain

Clinical / IMP Supply Plan

30–60 hours across clinical supply and QA building demand models, coverage tables, and distribution plans by hand.

Tech Transfer

Process Transfer Plan Author

~25–40 hrs per PTP document

Process Development

Process Development Report Author

~25–45 hrs per PDR document

Analytical Development

Analytical Development Report Author

~25–45 hrs per ADR document

Tech Transfer

Process Characterization Plan Author

~20–35 hrs per PCP document

Tech Transfer

Process Characterization Summary Author

~15–25 hrs per PCS document

Tech Transfer

Technology Transfer Summary Author

~35–50 hrs per TTS document

Tech Transfer

Scale-Down Model Qualification Report Author

~20–35 hrs per SDMQ Report

CQV

Process Validation Summary Author

~20–35 hrs per PVS document

Analytical Development

Analytical Validation Plan Author

~25–40 hrs per AVP document

Tech Transfer

Comparability Plan Author

~20–35 hrs per CP document

Tech Transfer

Knowledge Gap Assessment

~15–25 hrs per knowledge gap assessment

Quality Records

Data Integrity Assessment

Days across QA and IT — pulling configurations and access matrices by hand, mapping data flows, and cross-checking ALCOA+ against Part 11 and Annex 11.

Supply Chain

Master Batch Record (MBR)

30–60 hours across MSAT and production — drafting, formatting, and cross-checking every step and parameter by hand.

Business Development

Capability Pitch Deck

Days hunting through old decks, case studies, and quality records to assemble a story.

Analytical Development

Reference Standard Qualification

Business Operations

Capital Expenditure (CapEx) Justification

40–80 hours across finance, engineering, and manufacturing building the model and narrative by hand.

Business Operations

EHS Risk Assessment / Job Hazard Analysis

8–20 hours across EHS — walking the task, listing hazards by hand, scoring risk in a spreadsheet, and re-checking each control against OSHA and ISO 45001.

Quality Records

Quality Agreement

Tech Transfer

Process Transfer Plan Author

~25–40 hrs per PTP document

Process Development

Process Development Report Author

~25–45 hrs per PDR document

Analytical Development

Analytical Development Report Author

~25–45 hrs per ADR document

Tech Transfer

Process Characterization Plan Author

~20–35 hrs per PCP document

Tech Transfer

Process Characterization Summary Author

~15–25 hrs per PCS document

Tech Transfer

Technology Transfer Summary Author

~35–50 hrs per TTS document

Tech Transfer

Scale-Down Model Qualification Report Author

~20–35 hrs per SDMQ Report

CQV

Process Validation Summary Author

~20–35 hrs per PVS document

Analytical Development

Analytical Validation Plan Author

~25–40 hrs per AVP document

Tech Transfer

Comparability Plan Author

~20–35 hrs per CP document

Tech Transfer

Knowledge Gap Assessment

~15–25 hrs per knowledge gap assessment

Quality Records

Data Integrity Assessment

Days across QA and IT — pulling configurations and access matrices by hand, mapping data flows, and cross-checking ALCOA+ against Part 11 and Annex 11.

Supply Chain

Master Batch Record (MBR)

30–60 hours across MSAT and production — drafting, formatting, and cross-checking every step and parameter by hand.

Business Development

Capability Pitch Deck

Days hunting through old decks, case studies, and quality records to assemble a story.

Analytical Development

Reference Standard Qualification

Business Operations

Capital Expenditure (CapEx) Justification

40–80 hours across finance, engineering, and manufacturing building the model and narrative by hand.

Business Operations

EHS Risk Assessment / Job Hazard Analysis

8–20 hours across EHS — walking the task, listing hazards by hand, scoring risk in a spreadsheet, and re-checking each control against OSHA and ISO 45001.

Quality Records

Quality Agreement

Tech Transfer

Analytical Transfer Plan Author

~18–28 hrs per ATP document

Process Development

Process Development Summary Author

~30–50 hrs per PDS document

Analytical Development

Analytical Development Summary Author

~25–45 hrs per ADS document

Tech Transfer

Technology Transfer Plan Author

~20–35 hrs per TT Plan document

Tech Transfer

Process Transfer Summary Author

~20–30 hrs per PTS document

Tech Transfer

Scale-Down Model Qualification Plan Author

~20–35 hrs per SDMQ Plan

CQV

Process Validation Plan Author

~25–40 hrs per PVP document

CQV

Continued Process Verification Plan Author

~20–35 hrs per CPVP document

Analytical Development

Analytical Validation Protocol Author

~20–30 hrs per AVPr document

Tech Transfer

Comparability Protocol Author

~20–35 hrs per CPR document

Tech Transfer

Lifecycle Management Plan Author

~25–40 hrs per LMP document

Quality Records

Product Quality Review (APR/PQR)

20–40 hours across QA — pulling logs by hand, retyping tables, chasing reconciliation, and re-checking against the regulation.

Supply Chain

In-Process Control & Sampling Plan

15–30 hours building control tables and justifying sample sizes by hand against the standards.

CQV

Cleaning Validation

Analytical Development

Container Closure Integrity (CCI) Study

Supply Chain

Purchase Requisition / Sourcing Package

Hours spreadsheeting apples-to-oranges quotes by hand

Business Operations

Preventive Maintenance & Calibration Program

Days across metrology, QA, and facilities — reconciling registers, tolerances, intervals, and CMMS status by hand, then re-checking against ISO/IEC 17025 and Annex 15.

Supply Chain

Supply Chain Risk & Continuity Plan

Tech Transfer

Analytical Transfer Plan Author

~18–28 hrs per ATP document

Process Development

Process Development Summary Author

~30–50 hrs per PDS document

Analytical Development

Analytical Development Summary Author

~25–45 hrs per ADS document

Tech Transfer

Technology Transfer Plan Author

~20–35 hrs per TT Plan document

Tech Transfer

Process Transfer Summary Author

~20–30 hrs per PTS document

Tech Transfer

Scale-Down Model Qualification Plan Author

~20–35 hrs per SDMQ Plan

CQV

Process Validation Plan Author

~25–40 hrs per PVP document

CQV

Continued Process Verification Plan Author

~20–35 hrs per CPVP document

Analytical Development

Analytical Validation Protocol Author

~20–30 hrs per AVPr document

Tech Transfer

Comparability Protocol Author

~20–35 hrs per CPR document

Tech Transfer

Lifecycle Management Plan Author

~25–40 hrs per LMP document

Quality Records

Product Quality Review (APR/PQR)

20–40 hours across QA — pulling logs by hand, retyping tables, chasing reconciliation, and re-checking against the regulation.

Supply Chain

In-Process Control & Sampling Plan

15–30 hours building control tables and justifying sample sizes by hand against the standards.

CQV

Cleaning Validation

Analytical Development

Container Closure Integrity (CCI) Study

Supply Chain

Purchase Requisition / Sourcing Package

Hours spreadsheeting apples-to-oranges quotes by hand

Business Operations

Preventive Maintenance & Calibration Program

Days across metrology, QA, and facilities — reconciling registers, tolerances, intervals, and CMMS status by hand, then re-checking against ISO/IEC 17025 and Annex 15.

Supply Chain

Supply Chain Risk & Continuity Plan