Regulated Industry Infrastructure

Regulated Industry
Workflows

Aregis coordinates product development support, technical services and program management across sponsor personnel, independent consultants, and specialized service providers. The network supports pharmaceutical, biotechnology, medical device, and regulated manufacturing programs through shared planning and documented review.

Engagement scope

Select the Technical Support Your Program Requires

Engage Aregis for a technical assignment, remediation workstream, or cross-functional program. Select services according to product stage, applicable requirements, and program priorities.

Regulatory Strategy and CMC →Product Development and Industrialization →Quality Systems and Compliance →Program and Project Management →Supplier Quality and Outsourced Services Oversight →AI and Digital Process Implementation →

Defined Deliverables and Technical Accountability

The Aregis network brings subject-matter expertise and delivery capacity together across participating organizations. Shared deliverables, dependencies, and review records help identify deficiencies earlier, reduce avoidable rework, and improve delivery efficiency.

Scope and Acceptance Criteria

Specify deliverables, source records, responsibilities, schedules, and acceptance criteria before execution.

Dependency and Change Management

Identify prerequisites, outstanding inputs, and changes affecting technical activities and delivery dates.

Review and Supporting Records

Maintain source references, review dispositions, and completion records as work proceeds, supporting audit and submission preparation.

Specialist Coordination

Coordinate sponsor personnel, consultants, and service providers against shared deliverables and dependencies. Each participant retains its assigned technical, contractual, and review responsibilities.

Who We Help

Support for development-stage companies, growing operations, and established teams requiring specialized expertise or coordinated delivery for a defined program.

REGULATED PRODUCTS

Pharma, Biotech and Medical Device Teams

Teams preparing a product, quality system, submission, manufacturing process, audit, inspection, or remediation program.

REGULATED OPERATIONS

Manufacturing and Growing Operations

Organizations that need clearer quality controls, supplier oversight, validation, documentation, or coordination as operations grow.

CONTROLLED WORKFLOWS

AI, Digital, Contract and Supplier Teams

Teams introducing AI or digital tools, managing important contracts, or strengthening supplier processes where decisions and obligations must be traceable.

Engagement Management Through GAME Plan

GAME Plan provides a common engagement record across participating organizations: schedules, responsibilities, dependencies, decisions, and references to supporting records. Sponsor procedures and designated personnel govern technical review and acceptance.

Define Requirements and Deliverables

Record scope, responsibilities, prerequisites, due dates, and acceptance criteria.

Assign Responsibilities

Identify the personnel and organizations responsible for preparation, technical input, review, and approval.

Monitor Execution

Track delivery status, outstanding inputs, changes, and issues requiring disposition.

Document Review and Completion

Retain references to deliverables, supporting records, review dispositions, and acceptance evidence.

The shared-specification effort aims to make responsibilities, deliverables, and review records consistent across network participants. Sponsor-system integration is assessed and scoped separately.

Shared Specifications for Coordinated Work →

Technical Services

Select individual services or combine them into a program. Each engagement establishes deliverables, source requirements, responsibilities, and acceptance criteria. Qualified personnel retain responsibility for technical conclusions and regulated decisions.

Regulatory Strategy and CMC

TECHNICAL SERVICE

Pharmaceutical Regulatory Strategy and CMC

Develop pharmaceutical and biotechnology regulatory strategy and CMC plans. Coordinate technical content and partner deliverables for submissions and health-authority interactions.

IND, NDA, and BLA workstream support as applicable
CTD Module 3 preparation and technical review
Health-authority meeting preparation and response coordination
CDMO and CRO technical deliverable oversight

Intended benefit Align development activities and CMC content with the regulatory strategy.

TECHNICAL SERVICE

Regulatory Submission Preparation and Management

Prepare and manage IND, NDA, and BLA submission workstreams. Coordinate contributors, review content consistency, and manage outstanding inputs and health-authority responses.

IND preparation, amendments, and supporting documentation
NDA and BLA content preparation and coordination
CTD content planning, source references, and technical review
Submission schedules, outstanding inputs, and response coordination

Intended benefit Resolve content gaps earlier and maintain visibility of submission dependencies.

TECHNICAL SERVICE

Regulatory and Scientific Writing

Prepare and revise regulatory and scientific documents from controlled source records and subject-matter input. Coordinate authoring and review across related documents and submission sections.

IND, NDA, and BLA narratives and submission sections
CMC summaries and CTD Module 3 content
Scientific and technical reports and supporting summaries
Health-authority briefing documents and written responses

Intended benefit Improve factual support and consistency while reducing repeated document review.

TECHNICAL SERVICE

Sterile and Biologics CMC

Coordinate drug substance and drug product development for sterile, biologic, and long-acting injectable programs. Review process, analytical, and transfer deliverables with manufacturing partners.

Process and analytical characterization coordination
Technology-transfer planning and deliverable review
Development-stage manufacturing readiness
CDMO technical interfaces and issue management

Intended benefit Identify development and transfer gaps before they delay manufacturing readiness.

Review the development use case →

TECHNICAL SERVICE

Medical Device Regulatory and Design-Control Support

Support device regulatory planning, design-control documentation, and risk-management interfaces. Coordinate 510(k), PMA, or EU technical-documentation activities according to the product pathway.

Regulatory pathway and submission planning
Design input, verification, and validation documentation coordination
Risk-management interfaces
Technical-documentation review and outstanding-item tracking

Intended benefit Maintain consistency among intended use, design evidence, risk management, and submission content.

Review the development use case →

Product Development and Industrialization

TECHNICAL SERVICE

Product Development Planning and Execution Support

Translate product objectives and requirements into coordinated technical work packages. Connect sponsor teams and specialist partners through development milestones, dependencies, decisions, and review records.

Development-stage assessment and technical gap identification
Integrated development plans and specialist responsibilities
Requirements-to-evidence tracking and technical review coordination
Risk, decision, and development-change records

Intended benefit Identify missing inputs and unresolved technical dependencies earlier in development.

Review the detailed use case →

TECHNICAL SERVICE

Verification and Validation Coordination

Coordinate verification and validation plans, provider deliverables, and supporting records against agreed product requirements and acceptance criteria. Qualified specialists define methods and assess technical results within the engagement scope.

Requirements and acceptance-criteria alignment
Test-plan and specialist-provider coordination
Results, deviations, and outstanding-evidence tracking
Qualified technical review and disposition records

Intended benefit Improve visibility of the evidence required to support development decisions.

Review the detailed use case →

TECHNICAL SERVICE

Technology Transfer and Manufacturing Readiness

Coordinate the transfer of development outputs to manufacturing partners. Track process, analytical, supplier, documentation, and training prerequisites as applicable to the product and development stage.

Transfer plans and receiving-site responsibilities
Process and analytical deliverable coordination
Supplier and manufacturing-readiness gap assessment
Handoff criteria, outstanding actions, and closure records

Intended benefit Expose transfer gaps before they disrupt manufacturing preparation.

Review the detailed use case →

Quality Systems and Compliance

TECHNICAL SERVICE

Quality-System Development and Remediation

Assess, develop, or remediate quality-system processes against applicable requirements. Prepare prioritized actions, assigned responsibilities, and closure criteria.

Document control, change control, CAPA, and supplier quality
Risk management and process responsibilities
Multi-site and post-acquisition QMS alignment
Requirement-to-procedure and implementation-evidence assessment

Intended benefit Address procedural and implementation deficiencies with less repeated remediation.

Review the detailed use case →

TECHNICAL SERVICE

Procedure-to-Standard Gap Assessment

Compare controlled procedures and implementation records with applicable requirements. Deliver an evidence matrix, documented findings, assessment limitations, and remediation priorities.

Requirement-to-procedure and evidence matrix
Applicability and assessment limitations
Prioritized findings and responsible owners
Remediation actions and closure criteria

Intended benefit Distinguish missing procedure coverage from missing implementation evidence and focus corrective effort.

Review the detailed use case →

TECHNICAL SERVICE

Quality Auditing

Plan and conduct internal and supplier quality audits against defined criteria. Deliver audit reports, classified findings, and corrective-action follow-up under client independence and confidentiality requirements.

Audit scope, criteria, plan, and agenda
Supplier and service-provider quality audits
Internal quality-system and process audits
Audit reports, finding classification, and corrective-action follow-up

Intended benefit Provide independent assessment of operating practices and evidence for quality oversight.

TECHNICAL SERVICE

Inspection and Audit Readiness

Assess readiness for regulatory inspections, certification audits, or notified-body assessments. Coordinate remediation, record preparation, retrieval exercises, and finding responses.

Readiness gap assessment and prioritized remediation
Pre-approval inspection preparation
Mock reviews and record-retrieval exercises
Finding response and documented closure coordination

Intended benefit Identify material deficiencies earlier and improve access to supporting records.

Review the detailed use case →

TECHNICAL SERVICE

Complaint Investigation and Report Preparation

Review complaint records, document investigations, assess related events, and prepare reports under the client’s procedure. Preserve relevant facts and references to original records; qualified personnel determine conclusions and reporting decisions.

Controlled working-record preparation
Source-referenced technical findings
Related-complaint and trend assessment
Outstanding-item tracking and qualified review

Intended benefit Reduce incomplete investigation records and repeated review.

Review the detailed use case →

TECHNICAL SERVICE

CAPA Investigation and Documentation Support

Support individual CAPAs or manage a CAPA portfolio. Organize cause evaluations, action rationales, implementation records, and effectiveness assessments.

Cause-evaluation and action-rationale documentation
Owners, schedules, and implementation records
Effectiveness-assessment criteria and records
Backlog prioritization and closure tracking

Intended benefit Identify incomplete closure evidence and reduce avoidable review and rework.

Review the detailed use case →

TECHNICAL SERVICE

Combination-Product Quality and Design Support

Coordinate technical and quality activities across drug and device interfaces, including inhalation and other device-platform programs. Align design, risk, supplier, and quality-system records.

Design-control and quality-system interfaces
Risk-based verification planning and record review
Supplier qualification and technical coordination
Drug-device development dependencies

Intended benefit Resolve interface gaps that affect development and verification activities.

Review the development use case →

TECHNICAL SERVICE

Data-Integrity and Audit-Trail Remediation

Assess audit-trail review practices for manufacturing and analytical equipment. Coordinate backlog reviews, discrepancy investigations, remediation actions, and closure records.

Audit-trail review procedure assessment
Backlog assessment and controlled review coordination
Data discrepancy investigation support
Remediation actions and closure records

Intended benefit Strengthen record reliability and make unresolved discrepancies visible.

Program and Project Management

TECHNICAL SERVICE

Cross-Functional Program Management

Manage clinical, nonclinical, CMC, manufacturing, quality, and regulatory workstreams. Maintain integrated schedules, decision requirements, risks, and delivery status.

Development-stage planning and milestones
Clinical, DMPK, toxicology, and CMC interfaces
Issue, risk, and scope-change coordination
Management reporting and delivery tracking

Intended benefit Improve delivery predictability through earlier resolution of dependencies and decisions.

TECHNICAL SERVICE

Clinical Quality and Development Interfaces

Coordinate clinical operations, trial supply, quality, and regulatory interfaces. Maintain responsibilities, outstanding inputs, and study-to-submission dependencies.

Clinical trial supply quality procedures
Outsourced development and vendor oversight
Quality and regulatory deliverable coordination
Study-to-submission dependencies

Intended benefit Reduce gaps at organizational handoffs and improve visibility of development dependencies.

Supplier Quality and Outsourced Services Oversight

TECHNICAL SERVICE

Supplier and Service-Provider Oversight

Coordinate supplier requirements, technical deliverables, quality agreements, changes, and escalation. Maintain performance findings and records supporting deliverable acceptance.

CDMO, CRO, and specialist-provider coordination
Quality and contractual obligation tracking
Deliverable acceptance and change management
Performance findings and escalation

Intended benefit Align outsourced work with contractual commitments and quality obligations.

AI and Digital Process Implementation

TECHNICAL SERVICE

AI Application and Readiness Assessment

Assess proposed AI applications and deliver a prioritized readiness matrix covering intended use, required controls, training, and implementation prerequisites.

Intended-use and process assessment
Required controls and implementation prerequisites
Prioritized applications and responsible owners
Defined next steps for implementation

Intended benefit Focus implementation effort on suitable applications and unresolved prerequisites.

Review the detailed use case →

TECHNICAL SERVICE

AI Policy and Procedure Development

Prepare AI policies and procedures for controlled QMS implementation. Connect approved applications to forms, training, change control, data handling, and review requirements.

Approved applications and authorized tools
Data handling and output review requirements
Responsibilities and escalation
Change control and required records

Intended benefit Establish consistent operating responsibilities and review practices for approved AI use.

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TECHNICAL SERVICE

Role-Based Training on AI Use

Develop role-based AI training and assessments linked to current procedures and approved applications. Prepare completion records and identify retraining requirements.

Role-specific training content
Source verification and output review instruction
Understanding or competency assessment
Revision-linked completion records

Intended benefit Improve consistency in source verification, output review, and escalation.

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TECHNICAL SERVICE

Procedure-Based Training Development and Implementation

Develop source-referenced training materials and assessments, then coordinate review, release, assignments, and completion records. LMS configuration or software deployment requires a separate scope.

Procedure-to-role and training mapping
Training material and assessment development
Controlled review and release
Assignment and completion-record coordination

Intended benefit Keep training aligned with procedure revisions and assigned responsibilities.

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TECHNICAL SERVICE

AI-Assisted Process Evaluation

Evaluate a defined assessment or documentation task using client-approved tools. Compare accuracy, completeness, preparation time, review effort, and rework with an agreed baseline.

Defined deliverable and controlled inputs
Qualified review and acceptance criteria
Preparation, review, and rework measures
Documented evaluation and next-step disposition

Intended benefit Provide documented evidence to inform broader implementation decisions.

Review the detailed use case →

Client-approved AI tools may support engagements. Saga Agent and Convergence remain in active testing; participation requires an agreed task and applicable controls.

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Industry Expertise

Pharmaceuticals & Biotechnology

Product development and CMC coordination, technology transfer, regulatory strategy, quality systems, auditing, manufacturing readiness, and supplier oversight.

Medical Devices & Diagnostics

Product development support, design controls, risk management, verification and validation coordination, design transfer, regulatory submissions, and supplier controls.

Other Regulated Manufacturing

Quality systems, controlled processes, validation, supplier governance, audit readiness, remediation, and portfolio-level program management.

What an Engagement Looks Like

Define the technical objective and required expertise, then agree on deliverables, schedules, and responsibilities across participating entities. GAME Plan maintains the common coordination record as work proceeds.

See how an engagement works →