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Noralix Labs

One CRO Partner
for Your Drug Program

Formulation • Testing • Stability • Regulatory

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Dosage Form Categories
ICH Q1–Q14
Guidelines Covered
CTD/eCTD
Dossier Format Expertise

A partner built for modern development programs.

We are a pharmaceutical product development company providing comprehensive and flexible support ranging from partial assistance to complete end-to-end technology solutions — from product development to commercialization.

Formulation optimizationAnalytical validationPackaging compatibilityStability (ICH-aligned)CTD/eCTD support

Dosage form expertise

Pharmaceutical development across every major dosage form

Tablets, capsules, injectables, semi-solids, liquid orals, and dry powders — with development aligned to stability, scale-up, and regulatory-ready documentation.

View all expertise
Tablets pharmaceutical development01

Dosage form expertise

Tablets

Immediate or modified release development support with manufacturability in mind.

Examples

  • IR tablets
  • MR tablets
  • Coated tablets
Development & optimizationAnalytical strategyStability approachTransfer-ready deliverables
Capsules pharmaceutical development02

Dosage form expertise

Capsules

Capsule formulation support focusing on fill uniformity, stability, and scalability.

Examples

  • Hard gelatin capsules
  • HPMC capsules
  • Powder/blend fills
Development & optimizationAnalytical strategyStability approachTransfer-ready deliverables
Injectable formulations pharmaceutical development03

Dosage form expertise

Injectable formulations

Formulation and analytical support for sterile dosage forms and parenteral development needs.

Examples

  • Solutions
  • Suspensions
  • Lyophilized products (where applicable)
Development & optimizationAnalytical strategyStability approachTransfer-ready deliverables
Semi-solid dosage forms pharmaceutical development04

Dosage form expertise

Semi-solid dosage forms

Ointments, creams, and gels with focus on rheology, stability, and patient use.

Examples

  • Ointments
  • Creams
  • Gels
Development & optimizationAnalytical strategyStability approachTransfer-ready deliverables
Liquid orals pharmaceutical development05

Dosage form expertise

Liquid orals

Syrups, suspensions, and solutions with taste, stability, and dosing considerations.

Examples

  • Syrups
  • Suspensions
  • Solutions
Development & optimizationAnalytical strategyStability approachTransfer-ready deliverables
Dry powders & sachets pharmaceutical development06

Dosage form expertise

Dry powders & sachets

Powder blends and sachet presentations optimized for flow, uniformity, and stability.

Examples

  • Dry powders
  • Sachets
  • Granules
Development & optimizationAnalytical strategyStability approachTransfer-ready deliverables
WHAT WE DO

Pharmaceutical Development Services — From Formulation to Regulatory Filing

From early formulation decisions to stability, packaging compatibility, and CTD/eCTD-ready documentation.

Deliverables are tailored to your stage and target markets—focused on clarity, traceability, and transfer readiness.
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Formulation Development and Optimization
Prototype formulation design across all dosage forms — tablets, capsules, injectables, and semi-solids. Includes excipient screening, compatibility evaluation, and scale-up strategy with complete development documentation.
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Analytical Method Development and Validation
ICH Q2(R1)-compliant development and full validation of HPLC, UV, dissolution, and assay methods. Method transfer packages and system suitability protocols included.
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Packaging Development and Compatibility Studies
Primary and secondary packaging evaluation including extractables, leachables, and accelerated stress compatibility per ICH Q1B. Container closure integrity documentation provided.
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API/Excipients Vendor Qualification
Supplier audit frameworks, CoA review protocols, and vendor qualification reports to ensure GMP-compliant, traceable raw material sourcing for both APIs and functional excipients.
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Evaluation of Existing Formulation for Cost Reduction
Systematic gap analysis of current formulations to identify excipient substitution opportunities, process simplifications, and batch size efficiencies — without compromising quality or regulatory status.
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Ready-to-Compress Granules/Pellets
Wet granulation, dry granulation, and pelletization development with blend uniformity, flowability, and compressibility optimization. Scale-up and transfer documentation included.
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Stability Studies (ICH/Regulatory Guidelines)
Real-time and accelerated stability protocols per ICH Q1A(R2) — 25°C/60%RH, 30°C/65%RH, 40°C/75%RH zones. Includes degradation profiling, shelf-life determination, and regulatory-ready reports.
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Dossier Preparation and Regulatory Filing (CTD/eCTD)
Module 1-5 CTD compilation and eCTD-formatted submissions for FDA 505(b)(2), EMA MAA, CDSCO NDA/ANDAs, and WHO PQ dossiers. Pre-submission review support included.
Why choose us

Trust built through execution.

A high-integrity development partner focused on clarity, compliance, and measurable progress.
01
Scientifically Sound

Rigorous R&D approach with practical decisions that translate to manufacturing.

02
Regulatory Compliant

ICH/CTD/eCTD-oriented execution and documentation to reduce downstream rework.

03
Cost-Effective

Optimization strategies focused on meaningful cost drivers and scalable processes.

04
Flexible Engagement

From single-stage support to full technology transfer — we adapt to where you are in your development journey.

Workflow

Our Pharmaceutical Development Process — Product Brief to Commercialization

We align scope, deliverables, and documentation to match your stage and target markets.

Vertical timeline for reliability on mobile, with a scroll-drawn line and stage nodes that fill as you progress.
01
Product Brief & Feasibility
Understanding your molecule, target market, and regulatory pathway.
02
Formulation Development
Prototype development, excipient screening, and optimization cycles.
03
Analytical Method Development
Development, qualification, and validation of all required analytical methods.
04
Stability & Compatibility Studies
ICH-compliant stability chambers, packaging compatibility and shelf-life determination.
05
Dossier Preparation
CTD/eCTD module compilation and pre-submission regulatory review.
06
Technology Transfer & Commercialization
Complete tech transfer documentation and scale-up support for manufacturing.
FAQ

Frequently Asked Questions About Our Pharma CRO Services

Quick answers about our pharmaceutical development capabilities, ICH alignment, and regulatory deliverables.

What pharmaceutical development services does Noralixlabs offer?

We offer formulation development, analytical method validation, stability studies, packaging compatibility, vendor qualification, CTD/eCTD dossier preparation, and technology transfer — covering all dosage forms from tablets to injectables.

What dosage forms does Noralixlabs develop?

Tablets, capsules, injectable formulations, semi-solids (ointments/creams/gels), liquid orals (syrups/suspensions/solutions), and dry powders & sachets.

Is Noralixlabs ICH compliant?

Yes — all work is aligned to ICH Q1A(R2) for stability, ICH Q2(R1) for analytical validation, and ICH Q8-Q11 for pharmaceutical development.

Does Noralixlabs prepare CTD and eCTD dossiers?

Yes. We compile CTD Modules 1-5 and format eCTD submissions for FDA, EMA, CDSCO, and WHO regulatory filings.

Can Noralixlabs support technology transfer?

Yes. We provide complete tech transfer documentation and scale-up support from development to commercial manufacturing.

How do I get started?

Fill out our contact form with your molecule details and target market. We respond within 24 hours.