Global Market Expansion & Maintenance

Life Cycle Management

Our expertise lies in guiding companies through complex and evolving regulatory environments to ensure successful product registration and sustained compliance across diverse jurisdictions.

At Techsol, we enable life sciences and healthcare organizations to achieve and maintain global market access by providing strategic and operational regulatory support. Our expertise lies in guiding companies through complex and evolving regulatory environments to ensure successful product registration and sustained compliance across diverse jurisdictions.

From initial development through post-market lifecycle management, our Regulatory Strategy and Operations team provides end-to-end support aligned with both regional regulatory nuances and global health authority standards. By combining in-depth subject matter expertise, region-specific insights, and sophisticated regulatory intelligence tools, we expedite approval timelines, reduce compliance risk, and ensure regulatory strategies are closely aligned with your business goals.

Our approach includes:

Techsol is your trusted partner in navigating regulatory complexity ensuring your products reach the right markets efficiently and remain compliant throughout their lifecycle.

Country-Specific Dossier Adaptation for New Market Registrations

Expanding into new markets requires more than just a globally accepted dossier—it demands meticulous adaptation of regulatory submissions to align with country-specific formats, guidelines, and authority expectations.

At Techsol, we specialize in customizing regulatory dossiers to meet the unique requirements of individual health authorities across the globe. Our experienced Regulatory Affairs team ensures a smooth and compliant entry into new markets by tailoring content, structure, and data presentation based on local regulations.

Our Services Include:

Detailed comparison of the global/CTD dossier against target country requirements
Identification of country-specific gaps, data needs, and formatting expectations
Continuous tracking of regulatory updates and health authority communications

Customization of Modules 1–5 based on regional requirements (e.g., US FDA, EMA, TGA, PMDA, SFDA, ANVISA)
Preparation of region-specific Module 1 administrative and legal documents
Localization of product labels, patient leaflets, and risk management plans (RMPs)

Formatting dossiers in ICH/eCTD, NeeS, or paper-based formats, as applicable
Lifecycle submissions (variations, renewals) adapted to local authority specifications
Use of validated publishing tools to meet technical eCTD standards

Preparation of cover letters, application forms, and submission-ready files
Support for interactions with local agents or in-country regulatory representatives
Tracking submission milestones and responding to agency queries

Benefits of Country-Specific Dossier Adaptation

Accelerates market entry by reducing submission rejections or delays
Ensures full compliance with local regulatory laws, formats, and expectations
Minimizes risk of regulatory pushback, deficiency letters, or rework
Improves submission quality through structured, regionally optimized content
Supports strategic market expansion by aligning with regulatory roadmaps
Enables reuse of global content with minimal effort through smart adaptation
Builds credibility with regulators by demonstrating regulatory maturity and preparedness

Our Expertise and Value Proposition

Global Regulatory Intelligence & Local Insight: Our team brings deep knowledge of region-specific regulatory frameworks and agency preferences, ensuring dossier packages are not only compliant but strategically positioned
Seamless Integration with Global Submission Planning: Techsol aligns dossier adaptation with your global regulatory submission strategy, allowing for synchronized global launches or staggered submissions based on market priorities
Experienced in Multi-Region Dossier Rollouts: We have supported dossier adaptations and submissions across North America, Europe, APAC, LATAM and Africa, navigating complex variations in regulatory expectations
Flexible Resourcing and In-Country Support: Whether you need full ownership or supplemental support, we work closely with local affiliates, agents, and in-country regulatory consultants to bridge gaps in compliance and communication
Quality-Driven, Efficient Execution: Through our robust quality systems, SOPs, and regulatory publishing expertise, Techsol ensures that each submission package is accurate, technically sound, and audit-ready

Support for WHO prequalification and emerging market regulatory filings

Techsol provides end-to-end regulatory support for World Health Organization (WHO) Prequalification (PQ) programs and regulatory submissions in emerging markets critical pathways for ensuring the availability of quality-assured, safe, effective and quality-assured medicines in resource-limited settings.

Our regulatory team has extensive expertise in WHO PQ requirements and the regulatory frameworks of National Regulatory Authorities (NRAs) in regions such as Africa, Asia, and Latin America. We support applicants throughout the submission lifecycle, from technical dossier development and gap analysis to query responses and post-approval variations, ensuring full regulatory compliance with both global and local standards.

By applying regulatory intelligence, regional expertise, and knowledge of collaborative registration mechanisms such as the WHO Collaborative Registration Procedure (CRP) and reliance-based models, we help streamline submissions, reduce approval timelines, and support global health access goals through compliant and efficient market entry strategies.

Our Services Include

WHO Prequalification Dossier Preparation & Submission

Comprehensive gap analysis against WHO PQ dossier requirements
Preparation and compilation of Module 1 tailored to WHO format
Quality, clinical, and safety data alignment with WHO PQ standards
Coordination of product samples, batch certifications, and stability data
Management of the WHO PQ site inspections and queries

Emerging Market Regulatory Strategy & Filings

Customized regulatory intelligence and country-specific dossier adaptation for markets across Africa, Asia, Latin America, and the Middle East
Preparation of regulatory dossiers in formats accepted by local authorities (e.g., paper, eCTD, NeeS)
Support for registration, variation, and renewal submissions per regional timelines

Local Regulatory Agency Liaison & Communication

Engagement with national regulatory authorities and procurement bodies
Management of queries, deficiency responses, and inspection facilitation
Coordination with local agents, distributors, and partners for smooth filings

Post-Submission Compliance & Lifecycle Support

Ongoing monitoring of regulatory changes affecting WHO PQ and emerging market registrations
Support for Pharmacovigilance, manufacturing site changes, and product renewals
Maintenance of regulatory intelligence to anticipate emerging market trends and WHO updates

Our Expertise and Value Proposition

Specialized Expertise in WHO PQ & Emerging Markets: Our team has extensive experience managing WHO Prequalification dossiers and filings in markets across Africa, Asia, Latin America, and beyond, ensuring your products meet all necessary standards
End-to-End Regulatory Support: From dossier compilation to submission tracking and query management, Techsol offers full lifecycle support for WHO PQ and emerging market registrations
Deep Local Knowledge & Networks: We leverage strong relationships with local regulatory agencies, procurement bodies, and in-country partners to facilitate smooth regulatory processes
Flexible Engagement Models: Techsol tailors its support to meet your specific needs, whether it’s full project management or targeted regulatory consulting
Commitment to Quality and Compliance: We follow rigorous quality management systems and best practices to ensure regulatory deliverables meet or exceed expectations