Process Standardization - Techsol Life Sciences

Regulatory Affairs Services

Process Standardization

We address these challenges through end-to-end process standardization services tailored to U.S. FDA, EMA, Health Canada, PMDA, and ICH expectations. Whether you're preparing for your first IND or managing a portfolio of global submissions, we help streamline operations from SOP creation to automation-enabled dossier workflows.

Overview

In today’s fast-paced regulatory environment, life sciences companies must not only achieve compliance but sustain it across multiple products, regions, and functional teams. The lack of standardized processes often leads to inconsistent documentation, longer review cycles, and increased regulatory risk.

At Techsol, we address these challenges through end-to-end process standardization services tailored to U.S. FDA, EMA, Health Canada, PMDA, and ICH expectations. Whether you’re preparing for your first IND or managing a portfolio of global submissions, we help streamline operations from SOP creation to automation-enabled dossier workflows.

Process Standardization Consulting services:

Techsol has deep domain experience in regulatory process standardization across the key functional areas to drive consistency, compliance, and cross-functional synergy. We provide consulting services to Sponsors and research organizations on the following services on the Process Standardization.

Regulatory Operations

Standardized eCTD publishing workflows
Dossier compilation procedures
Health authority response management protocols

Clinical & Pharmacovigilance

SOPs for site activation, monitoring, and close-out
Serious Adverse Event (SAE) reporting workflows
Clinical and safety data reconciliation processes

Quality & Compliance

QMS documentation templates and versioning
Deviation and CAPA management procedures
Audit trail capture and oversight mechanisms

CMC & Manufacturing

Harmonized batch record documentation
Control strategy implementation workflows
Change control and notification procedures

Labeling Operations

Label version control and tracking
Regulatory compliance checks
CCDS (Company Core Data Sheet) harmonization

Clinical & Non-Clinical Process Alignment

Techsol has established a standard, and fully validated clinical and non-clinical templates which are acceptable by Regulatory authorities.

Clinical Reports
Clinical Overviews
Clinical Summaries
Integrated Clinical Reports
Non Clinical Reports
Non-Clinical Summaries
Non- Clinical Overviews

Our Expertise:

At Techsol, our deep industry experience and hands-on execution have enabled life sciences clients to standardize and streamline regulatory processes with precision. Our proven capabilities include:

We have successfully designed and implemented modular, audit-ready Standard Operating Procedures (SOPs) across diverse regulatory functions—including submissions, labeling, change control, and HA correspondence. These SOPs are tailored to product complexity and regional compliance expectations (ICH, USFDA, EMA, etc.).

Our team has developed validated, submission-ready templates and QA checklists for INDs, NDAs, BLAs, MAAs, DMFs, and labeling documents. These tools have accelerated submission preparation cycles while ensuring consistency, traceability, and completeness across teams.

We’ve integrated automation-ready workflows for eCTD publishing, version control, and submission tracking in real-world projects. This has enabled regulatory teams to reduce manual interventions, maintain control over content versions, and meet tight submission deadlines.

From USPI and CCDS to SmPC, SPL, and mock-ups, Techsol has built end-to-end labeling frameworks that support global harmonization. We’ve helped clients synchronize regional updates and minimize non-compliance risks during safety-driven labeling changes.

Techsol has supported multiple post-approval variation workflows by deploying structured SOPs, risk assessment matrices, and change control tools—enabling clients to manage global product changes effectively while maintaining continuous compliance.

Through cross-functional collaboration and standardization, we’ve helped clients establish harmonized regulatory practices across the U.S., EU, Canada, and APAC. Our frameworks are scalable across product types and therapeutic areas, supporting efficient multi-region submissions and lifecycle updates.

Our Value Proposition

15+ Years of Global Regulatory Expertise

Trusted partner supporting U.S., EU, APAC, LATAM, and MENA regulatory operations.
Led by Techsol SMEs with former roles at US FDA, EMA, and key international regulatory bodies.

Comprehensive Multi-Agency Compliance

Fully aligned with ICH, US FDA, EMA, Health Canada, PMDA, MHRA, TGA, LATAM, and MENA regulatory frameworks.
Ensures audit-ready submissions and robust global regulatory strategy.

End-to-End Product Lifecycle Management

Expertise spanning IND/IMPD, NDA/BLA/MAA submissions, and post-approval variations.
Supports faster time-to-market with smooth interactions across multiple health authorities.

Scalable & Flexible Solutions for Sponsors

Tailored frameworks for emerging biotech, mid-size pharma, and large global enterprises.
Adapts to varying regulatory complexities and submission volumes.

Validated, eCTD-Enabled & SOP-Driven Processes

Leverages proven SOPs, templates, and checklists from successful real-world submissions.
Reduces manual effort, minimizes rework, and accelerates submission readiness.