Regulatory Submissions Strategy

Regulatory Affairs

Regulatory Submissions strategy: IND, CTA, NDA, ANDA, BLA, MAA, DMF, ASMF & other Dossiers management Labeling and Artwork Compliance

Overview

In the dynamic regulatory landscape, getting submission strategy right is critical to minimizing delays, avoiding costly agency rejections, and accelerating product access to global markets. Whether you’re a biotech start-up submitting your first IND or a global pharma preparing for an MAA, Techsol delivers submission strategies with precision, speed, and regulatory confidence.

At Techsol, we support end-to-end dossier development, review, and lifecycle management for all major regulatory markets including the U.S., EU, Canada, LATAM, and APAC. With expertise spanning IND, CTA, NDA, ANDA, BLA, MAA, DMF, ASMF, and more, we provide scalable solutions tailored to your product type—be it a gene therapy, biologic, or small molecule.

Regulatory Submissions Strategy is a proactive, cross-functional plan that defines how regulatory documents are prepared, reviewed, compiled, and submitted to health authorities for product approvals and lifecycle management.

At Techsol, Regulatory Submissions Strategy goes beyond document delivery—it ensures that each submission is timely, complete, compliant with regional regulations like USFDA, EMA, PMDA), and aligned with the broader development and commercialization goals of the sponsor.

Goals of Strategy:

Accelerate review timelines
Ensure consistent global dossier alignment
Reduce submission rework and deficiencies
Facilitate successful interactions with health authorities

Scope of Regulatory Submissions Strategy

A comprehensive regulatory submissions strategy spans early development through post-approval phases, encompassing the following key areas:

Initial Applications

IND (Investigational New Drug), CTA (Clinical Trial Application)
NDA (New Drug Application), ANDA (Abbreviated NDA), BLA (Biologics License Application), MAA (Marketing Authorization Application)
Regional equivalents across global health authorities

Lifecycle Submissions

Amendments: Modifications submitted during the review of an initial application (e.g., protocol changes, manufacturing updates)
Variations (EU and other regions): Type IA, IB, and II variations based on risk and impact
Supplements (US FDA):
- Prior Approval Supplements (PAS) – For major changes requiring FDA approval before implementation (e.g., changes in manufacturing site, formulation, or container closure system)
- Changes Being Effected (CBE-0, CBE-30) – For moderate changes that can be implemented with or shortly after notification to the FDA
Renewals and Annual Reports to maintain marketing authorization and track post-approval commitments
Post-Approval Changes aligned with regional regulatory expectations and categorized based on risk/impact.

Techsol’s Regulatory Submission Excellence

At Techsol, our regulatory submission strategy is built on precision, proactive planning, and global compliance expertise. We understand that every product’s development pathway is unique and so are the regulatory expectations across different health authorities.

With over 15 years of experience with both investigational and marketing applications, we help clients avoid submission pitfalls by delivering:

From early-stage gap analysis to post-approval maintenance, our end-to-end services ensure submission readiness across clinical, nonclinical, and CMC domains.

With dedicated experts for Modules 1–5, we produce technically sound, regulator-friendly dossiers tailored to regional requirements and product-specific nuances.

We tailor CTD content and structure to meet region-specific regulatory expectations maximizing global submission success.

Our team has successfully led INDs, NDAs, BLAs, ANDAs, CTAs, MAAs, and DMFs across the US, EU, Canada, LATAM, and Asia-Pacific, including fast-track and orphan programs.

Using validated publishing tools and automated workflows, we maintain version control, ensure timely sequence delivery, and support global regulatory lifecycle management.

We work closely with CMC, clinical, and safety teams to ensure integrated submissions that align with development timelines and commercial goals.

Whether it’s your first submission or your 50th, Techsol’s regulatory team provides the clarity, compliance, and confidence needed for successful global filings.

Our Value Proposition

USFDA-Focused Expertise: Proven success in high-priority submissions (INDs, NDAs, ANDAs, BLAs), including support for accelerated approval programs such as Fast Track, Breakthrough, and RMAT (Regenerative Medicine Advanced Therapy).
Global Submission Experience: Comprehensive dossier management for EU, Health Canada, LATAM, APAC, and emerging markets, with localization and RMS/HMA coordination for EU centralized and decentralized procedures.
High-Quality Authoring & Review: Specialized scientific and regulatory writing teams ensure completeness, clarity, and technical accuracy.
Streamlined Submission Process: Integrated planning, gap assessment, and publishing tools reduce time to submission and agency response timelines.
Flexible Support Models: Whether you need full-service submission support or targeted assistance for specific modules, Techsol scales to your requirements.