Regulatory Consulting and Technical Support Services

Navigating the complex landscape of global regulatory requirements is one of the most challenging aspects of drug development. Our technical team at Nuvex Biotech can help you achieve compliance, streamline submissions, and accelerate approvals. With a deep understanding of global regulatory frameworks, we provide end-to-end support to ensure that the product meets the highest quality, safety, and efficacy standards.

CTD Dossier and Regulatory Submissions

We develop and compile Common Technical Document (CTD) dossiers for regulatory approvals, ensuring compliance with global agencies:

Module 2

(Summaries):

Provide technical summaries of quality, non-clinical, and clinical data.

Module 3

(Quality):

Document detailed drug, substance, and product information.

Module 4

(Non-Clinical):

Include toxicology and pharmacology studies.

Regulatory

submission:

Submission support for FDA, EMA, TGA, DRAP, MHRA, and WHO.

CMC Compliance

Ensure compliance with CMC (chemistry, manufacturing, and controls) requirements for regulatory submissions:

Drug substance and

product characterization:

Provide detailed manufacturing process and control documentation.

Specifications and

analytical methods:

Define quality standards and testing procedures.

Stability

data:

Include real-time and accelerated stability studies.

Raw material & excipient

characterization:

Ensuring quality and consistency.

GMP Compliance and Audits

Achieve and maintain Good Manufacturing Practice (GMP) compliance:

Guide GMP requirements and best practices.

Prepare SOPs, batch records, and quality manuals.

Conduct mock audits to prepare for regulatory inspections.

SOP development & quality system implementation.

Supplier & manufacturing facility qualification.

GLP & GDP compliance support for laboratories and distribution channels.

Drug Master Files (DMFs)

Prepare and submit Drug Master Files to regulatory agencies:

Type II

MFs:

Document drug substance, drug product, and excipient information.

Type III

DMFs:

Provide details on the packaging material.

Type IV

DMFs:

Include excipient, colorant, flavor, and fragrance information.

Submission & Post-Approval Technical Support (Ensuring Regulatory Success)

Our experts assist in regulatory submissions and post-approval maintenance:

FDA, EMA, TGA, DRAP regulatory filings & deficiency response management.

Post-approval variations & lifecycle management.

Regulatory strategy consulting for new market entry.

Advisory on label claims & product classification.

Why Choose
Our Technical Support Services?

End-to-end regulatory support from CTD dossier preparation to GMP audits & post-approval compliance.

Ensuring compliance with FDA, EMA, TGA, DRAP, WHO, and ICH guidelines.

Technical & Scientific Expertise – Specialized in CMC, DMF, GMP compliance, and regulatory submissions.

Streamlining regulatory processes to expedite approvals.

Dedicated project managers to provide ongoing support and updates.

Transparent processes to keep you informed at every stage of the regulatory journey.

Flexible engagement models to adapt to your budget and timeline.

Our Regulatory

Process

Initial
Consultation:

Understand your product, goals, and regulatory needs.

Regulatory
Strategy:

Develop a tailored strategy for submissions and compliance.

Document
Preparation:

Compile and review regulatory documents (CTD, CMC, DMFs, etc.).

Submission
Support:

File submissions and interact with regulatory agencies.

Post-Submission
Support:

Address queries, deficiencies, and post-approval requirements.