Regulatory filing Support
Regulatory Filing Support Services in Navi Mumbai, India
At Topiox Research, we provide end-to-end regulatory filing support to help pharmaceutical companies achieve timely approvals and maintain ongoing compliance with FDA, EMA, ICH, and CDSCO requirements.
From pre-submission strategy to deficiency response and post-marketing surveillance, our regulatory experts simplify complex submission pathways for NDA, ANDA, IND, and other global applications.
Our team combines scientific expertise, technical documentation, and regulatory insight to ensure every submission is accurate, compliant, and approval-ready.
Pre-Filing Activities
Before filing, careful preparation ensures that regulatory submissions are scientifically sound and strategically positioned for approval.
At Topiox Research, we support your pre-filing process through the following:
1. Regulatory Strategy
We define the most efficient regulatory pathway, whether NDA, ANDA, 505(b)(2), or IND, and outline the data requirements for successful submissions in compliance with FDA and ICH guidelines.
2. Developmental Aspects
Our team manages controlled correspondence, pre-submission meetings, and product development discussions with regulatory bodies to clarify requirements for complex products.
3. Controlled Correspondence Submission
We prepare and submit detailed communications to the U.S. FDA, seeking clarification on filing expectations, analytical methods, or bioequivalence requirements.
4. Pre-Submission Meetings
We organize and represent clients in meetings with regulatory agencies to discuss alternative pathways, data requirements, and expectations for complex generics or NDAs.
5. Product Development Meetings
We facilitate discussions with regulators to review CMC, clinical, and non-clinical requirements for complex formulations, ensuring development aligns with regulatory expectations.
6. Quality Management
We maintain a robust Quality Management System (QMS) that ensures every document and dataset meets global regulatory and audit standards.
Our integrated Analytical Testing Services and Method Validation programs support CMC documentation, impurity data, and stability studies required for successful regulatory filings.
Filing Categories We Support
Topiox Research provides comprehensive filing support for a wide range of product categories and submission types:
NDA (New Drug Application): For new chemical entities or novel formulations requiring full clinical and non-clinical data.
ANDA (Abbreviated New Drug Application): For generic versions of approved drugs, supported by bioequivalence and Q3/IVRT data.
IND (Investigational New Drug): For new drugs or formulations in clinical development.
PAS (Prior Approval Supplements): For major post-approval changes such as formulation or manufacturing site modifications.
CBE-0 and CBE-30 (Change Being Effected): For moderate post-approval updates.
AR (Annual Report): For minor product changes reported annually.
Post-Marketing Surveillance (PMS): Continuous monitoring of product safety, performance, and compliance in the marketplace.
Submission Process
Our regulatory submission process ensures every filing is clear, complete, and compliant with the required standards.
1. Submission Preparation
Compilation and electronic submission (eCTD) of complete FDA-compliant documentation packages for NDA, ANDA, IND, or post-approval updates.
2. Regulatory Review
Regulatory authorities (FDA, EMA, or CDSCO) review your submission for scientific accuracy, data completeness, and adherence to applicable regulations.
3. Deficiency Response Management
We handle all regulatory deficiency queries promptly and effectively, providing detailed justifications, additional data, or revised documentation to meet agency expectations.
4. Approval and Post-Approval Support
Upon approval, we support product launch activities, ongoing regulatory maintenance, and post-marketing compliance, ensuring your product remains aligned with evolving standards.
Understanding the FDA 505(b)(1), 505(b)(2), and ANDA Pathways
505(b)(1) NDA Pathway
Used for new drug entities (NDEs) requiring full clinical trial data. Ideal for innovators developing new molecules.
505(b)(2) NDA Pathway
Designed for drugs with existing data references (e.g., modified dosage forms, new combinations). It reduces time and cost for approvals while ensuring safety and efficacy.
Abbreviated New Drug Application (ANDA)
Focused on generic drug development, this pathway allows approval based on bioequivalence to an existing reference listed drug (RLD), without repeating full clinical trials.
Topiox Research provides comprehensive support for CMC documentation, Q3 and IVRT/IVPT studies, and bioequivalence assessments as part of ANDA submissions.
Post-Marketing Surveillance and Lifecycle Management
Regulatory compliance doesn’t end at approval.
We provide Post-Marketing Surveillance (PMS) and lifecycle management services to maintain safety, quality, and global regulatory alignment.
Our services include:
- FDA Post-Marketing Safety Monitoring
- Adverse Event Reporting (AER)
- Periodic Safety Update Reports (PSUR/PBRER)
- Risk Evaluation and Mitigation Strategies (REMS)
- Regulatory Change Management
Why Choose Topiox Research for Regulatory Filing Support?
End-to-End Regulatory Expertise
Our regulatory team brings years of hands-on experience in managing NDA, ANDA, IND, and CMC submissions. We specialize in aligning technical documentation with evolving FDA, EMA, and ICH expectations, ensuring a smooth review process.
Integrated Technical and Analytical Capabilities
Unlike typical consulting firms, Topiox Research operates as a full-service analytical and regulatory partner. Our in-house analytical testing, method validation, and stability studies directly support your CMC sections, minimizing delays and ensuring data consistency across modules.
Regulatory Intelligence and Strategy
We continuously track global regulatory trends, updated FDA guidances, and ICH revisions, allowing us to offer proactive advice on dossier structure, labeling, and submission timelines. This strategic foresight helps reduce review cycles and potential deficiencies.
Documentation Quality and Compliance
Every submission undergoes multiple layers of technical review, data verification, and QMS checks to ensure accuracy and regulatory compliance. Our documentation is audit-ready and prepared to withstand global inspections
Faster Turnaround and Efficiency
We understand time-to-market pressures. Our streamlined workflows, digital submission systems, and experienced project managers ensure timely delivery of submission-ready dossiers, without compromising on quality.
Tailored Solutions for Every Market
Whether you’re filing in the U.S., Europe, India, or ROW markets, our team adapts documentation formats, testing data, and regional requirements to meet specific regulatory expectations.
Frequently Asked Questions (FAQ)
Regulatory filing support involves preparing, compiling, and submitting technical documentation to health authorities to obtain market authorization.
The most common filing types include NDA, ANDA, IND, PAS, CBE, and Annual Reports (AR).
They provide an opportunity to align product data with regulatory expectations, reducing delays and deficiencies.
It involves monitoring a drug’s safety and efficacy after it reaches the market to ensure continued compliance and patient safety.
By combining scientific expertise, precise documentation, analytical testing integration, and proactive agency communication for faster and smoother approvals.
Contact Us for Expert regulatory filing and post-marketing support
Contact Topiox Research today for expert regulatory filing and post-marketing support services in Navi Mumbai, India.