pharma

PHARMA — Pharma & Life Sciences

Capability overview

Code: PHARMA Full name: Pharma & Life Sciences Description: Pharma & life sciences — GxP, clinical trials, pharmacovigilance, regulatory filings (FDA / EMA / GCC).

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Skills index

#	Skill	Command	Purpose
1	GxP Readiness	/cps-pharma:gxp-readiness	Assess GxP (GMP/GLP/GCP/GDP) readiness; identify control gaps.
2	Clinical Trial Design Review	/cps-pharma:trial-design	Review clinical trial protocol design and statistical approach.
3	Pharmacovigilance Process	/cps-pharma:pv-process	Assess PV process including ICSR handling, signal detection, PSUR/PBRER.
4	Regulatory Strategy	/cps-pharma:regulatory-strategy	Define filing strategy across FDA / EMA / GCC including pathway selection.
5	Launch Readiness	/cps-pharma:launch-readiness	Assess launch readiness across supply, market access, medical, commercial.

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Skill 1: GxP Readiness

Command: /cps-pharma:gxp-readiness

Purpose

Assess GxP (GMP/GLP/GCP/GDP) readiness; identify control gaps.

Inputs required

client:
  name: "Client Name"
  industry: "Industry"
context:
  scope: "in-scope description"
  constraints: ["constraint 1", "constraint 2"]
references:
  - "Prior deliverable / document name"
  - "External benchmark / source"

Methodology

1. Frame. Translate client request into a structured problem statement and hypotheses.
2. Gather. Pull data from engagement brain, client documents, and external sources.
3. Analyze. Apply the GxP Readiness method using domain frameworks (see Frameworks section of the agent).
4. Synthesize. Produce primary deliverable with recommendations, evidence, and risks.
5. Validate. Run /cps:verify-quality and pass through GxP findings link to specific regulation (21 CFR 211, ICH Q7, etc.).

Output shape

A CPS-branded GxP Readiness deliverable in 05_Deliverables_Final/. Pyramid-Principle structured, sourced, and reviewed.

Quality checklist

• GxP findings link to specific regulation (21 CFR 211, ICH Q7, etc.)
• Trial design comments reference ICH E9 / E10 / GCP
• PV findings cite EMA GVP modules / FDA 21 CFR 314.80

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Skill 2: Clinical Trial Design Review

Command: /cps-pharma:trial-design

Purpose

Review clinical trial protocol design and statistical approach.

Inputs required

client:
  name: "Client Name"
  industry: "Industry"
context:
  scope: "in-scope description"
  constraints: ["constraint 1", "constraint 2"]
references:
  - "Prior deliverable / document name"
  - "External benchmark / source"

Methodology

1. Frame. Translate client request into a structured problem statement and hypotheses.
2. Gather. Pull data from engagement brain, client documents, and external sources.
3. Analyze. Apply the Clinical Trial Design Review method using domain frameworks (see Frameworks section of the agent).
4. Synthesize. Produce primary deliverable with recommendations, evidence, and risks.
5. Validate. Run /cps:verify-quality and pass through GxP findings link to specific regulation (21 CFR 211, ICH Q7, etc.).

Output shape

A CPS-branded Clinical Trial Design Review deliverable in 05_Deliverables_Final/. Pyramid-Principle structured, sourced, and reviewed.

Quality checklist

• GxP findings link to specific regulation (21 CFR 211, ICH Q7, etc.)
• Trial design comments reference ICH E9 / E10 / GCP
• PV findings cite EMA GVP modules / FDA 21 CFR 314.80

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Skill 3: Pharmacovigilance Process

Command: /cps-pharma:pv-process

Purpose

Assess PV process including ICSR handling, signal detection, PSUR/PBRER.

Inputs required

client:
  name: "Client Name"
  industry: "Industry"
context:
  scope: "in-scope description"
  constraints: ["constraint 1", "constraint 2"]
references:
  - "Prior deliverable / document name"
  - "External benchmark / source"

Methodology

1. Frame. Translate client request into a structured problem statement and hypotheses.
2. Gather. Pull data from engagement brain, client documents, and external sources.
3. Analyze. Apply the Pharmacovigilance Process method using domain frameworks (see Frameworks section of the agent).
4. Synthesize. Produce primary deliverable with recommendations, evidence, and risks.
5. Validate. Run /cps:verify-quality and pass through GxP findings link to specific regulation (21 CFR 211, ICH Q7, etc.).

Output shape

A CPS-branded Pharmacovigilance Process deliverable in 05_Deliverables_Final/. Pyramid-Principle structured, sourced, and reviewed.

Quality checklist

• GxP findings link to specific regulation (21 CFR 211, ICH Q7, etc.)
• Trial design comments reference ICH E9 / E10 / GCP
• PV findings cite EMA GVP modules / FDA 21 CFR 314.80

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Skill 4: Regulatory Strategy

Command: /cps-pharma:regulatory-strategy

Purpose

Define filing strategy across FDA / EMA / GCC including pathway selection.

Inputs required

client:
  name: "Client Name"
  industry: "Industry"
context:
  scope: "in-scope description"
  constraints: ["constraint 1", "constraint 2"]
references:
  - "Prior deliverable / document name"
  - "External benchmark / source"

Methodology

1. Frame. Translate client request into a structured problem statement and hypotheses.
2. Gather. Pull data from engagement brain, client documents, and external sources.
3. Analyze. Apply the Regulatory Strategy method using domain frameworks (see Frameworks section of the agent).
4. Synthesize. Produce primary deliverable with recommendations, evidence, and risks.
5. Validate. Run /cps:verify-quality and pass through GxP findings link to specific regulation (21 CFR 211, ICH Q7, etc.).

Output shape

A CPS-branded Regulatory Strategy deliverable in 05_Deliverables_Final/. Pyramid-Principle structured, sourced, and reviewed.

Quality checklist

• GxP findings link to specific regulation (21 CFR 211, ICH Q7, etc.)
• Trial design comments reference ICH E9 / E10 / GCP
• PV findings cite EMA GVP modules / FDA 21 CFR 314.80

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Skill 5: Launch Readiness

Command: /cps-pharma:launch-readiness

Purpose

Assess launch readiness across supply, market access, medical, commercial.

Inputs required

client:
  name: "Client Name"
  industry: "Industry"
context:
  scope: "in-scope description"
  constraints: ["constraint 1", "constraint 2"]
references:
  - "Prior deliverable / document name"
  - "External benchmark / source"

Methodology

1. Frame. Translate client request into a structured problem statement and hypotheses.
2. Gather. Pull data from engagement brain, client documents, and external sources.
3. Analyze. Apply the Launch Readiness method using domain frameworks (see Frameworks section of the agent).
4. Synthesize. Produce primary deliverable with recommendations, evidence, and risks.
5. Validate. Run /cps:verify-quality and pass through GxP findings link to specific regulation (21 CFR 211, ICH Q7, etc.).

Output shape

A CPS-branded Launch Readiness deliverable in 05_Deliverables_Final/. Pyramid-Principle structured, sourced, and reviewed.

Quality checklist

• GxP findings link to specific regulation (21 CFR 211, ICH Q7, etc.)
• Trial design comments reference ICH E9 / E10 / GCP
• PV findings cite EMA GVP modules / FDA 21 CFR 314.80

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Cross-skill workflows

Discovery → /cps-pharma:gxp-readiness → /cps-pharma:trial-design → Recommendations

Integration with other CPS plugins

Plugin	Integration point
cps-iso	ISO 13485 medical-device QMS
cps-cyber	GxP system validation security
cps-ai-regs	Regulatory horizon scan (FDA / EMA guidance)

Templates & artifacts

All deliverables use standard CPS branding via:

• /doc-gen for document generation
• assets/cps-branding.json for styling
• scripts/cps-document-generator.js for automation

Skill	Primary artifact	Format
/cps-pharma:gxp-readiness	GxP Readiness Report	DOCX/PDF
/cps-pharma:trial-design	Clinical Trial Design Review Report	DOCX/PDF
/cps-pharma:pv-process	Pharmacovigilance Process Report	DOCX/PDF
/cps-pharma:regulatory-strategy	Regulatory Strategy Report	DOCX/PDF
/cps-pharma:launch-readiness	Launch Readiness Report	DOCX/PDF