Regulatory Life Cycle Management

Life Cycle Management

End-to-end regulatory support across the full product life cycle

Effective Life Cycle Management (LCM) is a regulatory imperative for sustaining product quality, maintaining compliance, and ensuring uninterrupted market presence.

At Techsol, we deliver end-to-end regulatory support across the full product life cycle from initial marketing authorization through post-approval maintenance and global expansion. Effective Life Cycle Management (LCM) is a regulatory imperative for sustaining product quality, maintaining compliance, and ensuring uninterrupted market presence.

Our LCM services encompass a broad range of post-approval regulatory activities, including:

Preparation and submission of regulatory variations, supplements, and renewals in alignment with regional requirements
Management of Chemistry, Manufacturing, and Controls (CMC) updates, safety-related changes, and labeling modifications
Development and execution of globally harmonized change control strategies
Continuous monitoring of regulatory landscapes and impact assessments for proactive compliance
Adherence to evolving international and local regulatory guidelines and frameworks

Through a strategic, risk-based regulatory approach, Techsol enables sponsors to maintain the compliance integrity of their products, reduce regulatory delays, and adapt effectively to changes in requirements. Our integrated global support ensures consistent regulatory engagement and timely execution of life cycle activities across all relevant markets.

Post-Approval Supplements

At Techsol, we specialize in providing comprehensive regulatory support for the preparation and submission of Post-Approval Supplements (PAS) to ensure ongoing compliance with FDA requirements. As part of a strategic approach to lifecycle management, we help pharmaceutical manufacturers navigate post-marketing changes efficiently and compliantly.

Our regulatory team manages all supplement types including CBE-0, CBE-30, and Prior Approval Supplements (PAS) supporting changes related to manufacturing processes, formulation, labeling, and packaging. We ensure proper classification of each change, complete and accurate dossier preparation, and timely submission to facilitate FDA review, reduce approval timelines, and maintain uninterrupted product availability.

Our Services Includes:

Techsol supports all categories of FDA post-approval supplements, with precision and compliance at the core of our services:

CBE-0 (Changes Being Effected – Immediate Implementation): Submissions for changes that may be implemented immediately upon FDA receipt. Our team prepares and submits supporting documentation concurrently to meet regulatory expectations.
CBE-30 (Changes Being Effected in 30 Days): For moderate changes, Techsol ensures submission of all required data 30 days prior to implementation, enabling clients to proceed with confidence upon FDA clearance.
PAS (Prior Approval Supplements): For significant changes requiring FDA review and approval before implementation, our regulatory experts craft robust submission packages to minimize review cycles and mitigate risk of delays.

Our Expertise

At Techsol, we bring deep regulatory expertise and a proactive approach to managing post-approval changes across global markets. Here’s why leading pharmaceutical companies trust us:

End-to-End Support: From strategy development to submission and agency follow-up, we manage the complete lifecycle of post-approval changes
Global Regulatory Expertise: Proficient in FDA, EMA, and other major regulatory authorities' requirements for supplements, variations, and amendments
Accurate Change Classification: We perform impact assessments and determine the correct supplement type, reducing the likelihood of FDA rejections or resubmissions
Submission Excellence: Our team delivers fully compliant, submission-ready dossiers (eCTD/NeeS), ensuring timely and successful filings

Variations (Type IA, IB, II for EU, CP/MRP/DCP/National)

Effective lifecycle management of medicinal products within the EU requires a structured and compliant approach to handling regulatory variations. Changes to the terms of a marketing authorization (MA) are classified by the European Medicines Agency (EMA) and national competent authorities into Type IA, Type IB, and Type II variations, based on the potential impact on product quality, safety, and efficacy.

Each variation type is governed by specific regulatory guidelines, defined timelines, and procedural requirements. Regulatory strategies must align with the applicable submission routes Centralized (CP), Decentralized (DCP), Mutual Recognition (MRP), or purely National procedures to ensure timely implementation and uninterrupted product availability.

At Techsol, we provide end-to-end regulatory support for the classification, preparation, and submission of variations in accordance with the European Union (EU) regulatory framework, enabling Marketing Authorization Holders (MAHs) to maintain ongoing compliance while efficiently managing post-approval product changes.

Our regulatory experts ensure precise determination of variation type, appropriate documentation, and adherence to procedural requirements, whether changes are administrative, quality-related, or impact the safety or efficacy of the product.

Techsol Expertise Across EU Variation Types

We provide regulatory support across all categories of EU variation submissions:

Type IA Variations: Minor changes with no significant impact on quality, safety, or efficacy. These are submitted as post-implementation notifications, without requiring prior approval from the competent authority
Type IB Variations: Moderate changes that are not classified as Type IA or Type II. These require prior notification and regulatory assessment. Techsol ensures accurate variation scope definition and timely submission to avoid review delays
Type II Variations: Major changes that may significantly affect product quality, safety, or efficacy. These require a comprehensive scientific evaluation, and we support dossier preparation, justification development, and authority engagement for favorable outcomes

Support Across All EU Regulatory Procedures

Techsol manages variation submissions through all applicable EU regulatory pathways:

Mutual Recognition Procedure (MRP): For products authorized in one Member State, we coordinate submission to the RMS, manage communication with CMS, and support responses to regulatory questions for recognition across additional Member States.
Decentralized Procedure (DCP): For new products seeking parallel approvals in multiple EU Member States, we manage dossier preparation, procedural timelines, and regulatory interactions to ensure a harmonized review and approval process.
National Procedure: For country-specific variations, we adapt submission strategies to meet national requirements and maintain close coordination with local health authorities to secure timely approvals.

Value Proposition

Renewals and Reassessments

MA Renewals are regulatory submissions required to extend the validity of a product’s marketing authorization after its initial approval period (commonly 5 years in the EU and many other regions). After the renewal is granted, the authorization typically becomes indefinite, provided the product continues to meet regulatory requirements.

Reassessments are formal regulatory reviews of an already authorized product to ensure its ongoing benefit-risk balance remains positive. These may be routine (e.g., periodic) or triggered by safety signals, new scientific data, or changes in guidelines.

Techsol’s offers end-to-end support for Marketing Authorization (MA) Renewals and Reassessments, ensuring full compliance with global regulatory requirements. Our approach to renewals includes the systematic collection and analysis of updated safety, efficacy, and quality data, including critical documentation such as Periodic Safety Update Reports (PSURs) and benefit-risk evaluations. We prepare and maintain the required dossier components particularly Module 1 and updated sections of Modules 2 to 5 and manage timely submissions to Health Authorities to avoid any disruption in market authorization.

For reassessments, Techsol provides strategic oversight by identifying regulatory or safety-driven triggers, reviewing cumulative clinical and post-marketing data, and conducting robust benefit-risk assessments. Where applicable, we manage interactions with Health Authorities to support label updates, usage restrictions, or re-evaluation requests. Our regulatory professionals ensure that your product remains aligned with the latest scientific evidence and regulatory expectations, enabling long-term market continuity and patient safety.

Our Services Include:

Our Expertise and Value proposition

Comprehensive Renewal & Reassessment Management: End-to-end support for MA renewals, re-evaluations, and regulatory reassessments across global markets
Global Regulatory Expertise: Deep knowledge of FDA, EMA, MHRA, Health Canada, TGA, and other regional requirements to ensure compliance and timely approvals
Strategic Submission Planning & Dossier Management: Proactive timeline tracking, Modules 1–5 compilation, and ongoing dossier maintenance to prevent lapses
Data Integration & Gap Analysis: Consolidation of safety, efficacy, and quality data with early identification of gaps for corrective actions
Benefit-Risk Assessment & Scientific Justification: Robust evaluation aligned with clinical and post-marketing evidence to support regulatory decisions
Regulatory Intelligence & HA Engagement: Continuous monitoring of evolving requirements and direct liaison with health authorities to address queries efficiently
Technology-Driven Regulatory Operations: Digital tools and regulatory platforms enable efficient tracking, workflow management, and submission readiness

Labeling updates (USPI, SmPC, PIL, CCDS)

At Techsol, we understand the critical importance of maintaining accurate and compliant product labeling throughout the product lifecycle. Our regulatory experts provide end-to-end support for the preparation, review, and submission of labeling updates to meet evolving regulatory requirements across global markets.

We manage a wide range of labeling documents, including:

Our Regulatory team will ensure that the all labeling changes whether prompted by new safety data, regulatory requests, or company-driven updates are accurately reflected, scientifically justified, and compliant with regional Health Authority guidelines.

Our Services Include:

Preparation and revision of core labelling documents including:

US Package Inserts (USPI)
Summary of Product Characteristics (SmPC)
Patient Information Leaflets (PIL)
Company Core Data Sheets (CCDS)

Benefits of Effective Labeling & Promotional Support

Ensures full compliance with applicable legal, regulatory, and industry standards
Minimizes risk of regulatory penalties, fines, and product recalls by providing accurate, and clear information
Prevents misleading, false, or deceptive claims in both labelling and promotional materials
Enhances transparency and truthful communication to protect consumer rights and safety
Facilitates regulatory inspections, audits, and documentation requirements with consistent product information
Supports traceability, accountability, and supply chain integrity through clear labelling and aligned promotional content
Promotes ethical marketing practices and adherence to corporate social responsibility guidelines
Reduces regulatory scrutiny by aligning promotional claims strictly with approved labelling and product data
Builds trust and credibility with regulators, consumers, and stakeholders through compliance and transparency
Helps maintain market access and competitive advantage by meeting evolving regulatory demands

Our Expertise and Value Proposition

Proven Global Regulatory Expertise: Over 500+ labeling submissions delivered, with in-depth knowledge of US FDA, EMA
Process Standardization and Best Practices: Well-defined workflows for labeling updates and change submissions minimize delays, regulatory risks, and ensure high-quality deliverables
Harmonized Global Labeling Strategy: Support for consistent labeling across global markets while meeting country-specific requirements and maintaining regulatory alignment
Agile Response to Regulatory Changes: Rapid integration of safety updates and urgent directives into USPI, SmPC, PIL, and CCDS documents to maintain market readiness
End-to-End Lifecycle Support: Comprehensive management from document drafting, version control, and cross-functional coordination to complete regulatory submission support

Management of Electronic Regulatory Dossiers (eCTD / NeeS Formats)

Techsol offers end-to-end support for the creation, submission, and lifecycle management of electronic regulatory dossiers in compliance with eCTD (Electronic Common Technical Document) and NeeS (Non-eCTD electronic Submission) standards. We ensure your product dossiers remain compliant, submission-ready, and aligned with Health Authority expectations throughout the lifecycle of the product.

Our regulatory operations team specializes in dossier planning, compilation, publishing, and version control to facilitate seamless submissions across global regulatory agencies including the FDA, EMA, MHRA, Health Canada, and others.

Our Services Include:

Initial dossier setup in eCTD or NeeS format
Lifecycle maintenance, including updates for variations, supplements, renewals, and responses to authority queries
Gap analysis and conversion of legacy dossiers from paper or NeeS to eCTD format
Validation and quality checks using industry-standard publishing tools
Submission planning and tracking, ensuring timely delivery and acknowledgment by Health Authorities
Metadata management, folder structure alignment, and document granularity support for high-quality submissions
Archiving and version control of all submitted dossiers to maintain audit readiness and regulatory transparency

Expertise and Value Proposition

Global Submission Expertise: We manage region-specific requirements for eCTD/NeeS across the US, EU, Canada, APAC, and other major markets
Regulatory Publishing Excellence: Our team uses validated industry tools and follows strict quality control protocols to deliver error-free, HA-compliant submissions
Efficient Lifecycle Updates: Techsol supports dossier maintenance for a wide range of submission types, including post-approval changes, safety updates, and labeling variations
Digital Compliance and Readiness: We keep your regulatory dossiers current, organized, and aligned with Health Authority expectations—reducing risk and ensuring faster approvals

Change control and regulatory impact assessments

At Techsol, we offer strategic support for change control and regulatory impact assessments, helping pharmaceutical and biotech companies manage internal changes while ensuring global regulatory compliance.

Whether the change involves manufacturing, packaging, labeling, testing, or supply chain activities, we provide a risk-based evaluation of the regulatory impact and guide the appropriate submission strategy. Our regulatory experts collaborate closely with cross-functional teams to ensure changes are implemented efficiently with no disruption to market authorization or supply continuity.

Our Services Include:

Our Expertise and Value Proposition

End-to-End Regulatory Insight: We understand the full lifecycle impact of changes and ensure your regulatory decisions are aligned with business needs and HA expectations
Global Experience: Our team handles change assessments and submissions across major markets, ensuring alignment with local and international regulatory frameworks
Risk-Based Approach: We apply ICH Q9 principles and agency guidelines to assess change impact, ensuring a defensible and efficient regulatory strategy
Lifecycle Compliance Management: Techsol helps you maintain product integrity and compliance from development through commercialization even as your operations evolve