Pharmaceutical Research & Innovation

Advancing Science.Improving Lives.

Advanced pharmaceutical research, analytical testing, and scientific solutions designed to help organizations accelerate innovation.

About Solunist Research

From Research & Development to Global Compliance

Solunist Research is a science-driven consulting firm helping organizations transform innovative ideas into practical, compliant, and market-ready solutions. We bring together scientific expertise, industry knowledge, regulatory insight, and a practical approach to help our clients navigate complex challenges across healthcare and life sciences.

From innovation and development to compliance and market readiness, we work alongside our clients to create solutions that are credible, effective, and built for real-world success.

Scientific Excellence

Combining scientific expertise, advanced methodologies, and rigorous research practices to deliver meaningful results.

Quality & Compliance

Structured processes and quality-focused workflows designed to maintain accuracy, reliability, and consistency.

Innovation Driven

We continuously explore better technologies, methods, and approaches to solve complex pharmaceutical challenges.

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Our Services

Comprehensive Pharmaceutical And MedTech Solutions

From regulatory strategy and quality management to product development, scientific consulting, and post-market surveillance, we provide specialized support across the product lifecycle.

Regulatory Affairs & Market Access

Strategic regulatory guidance and market access support across global pharmaceutical and medical device pathways.

  • FDA 510(k) Strategy & Submission Support
  • EU MDR / CE Marking & Submission Support
  • SFDA & TGA Regulatory Strategy
  • Medical Device Classification
  • SaMD Regulatory Strategy
  • Global Regulatory Pathway Selection
  • Pre-Submission Planning
  • Regulatory Gap Assessment
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Quality Management & Compliance

Quality systems and compliance solutions designed to strengthen regulatory readiness and operational excellence.

  • ISO 13485 QMS Implementation
  • ISO 14971 Risk Management
  • IEC 62304 Software Lifecycle
  • IEC 62366 Usability Engineering
  • Internal & Supplier Audits
  • CAPA & Change Control
  • GAP Analysis
  • Good Documentation Support
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Technical & Clinical Documentation

Comprehensive technical and clinical documentation support aligned with regulatory and product requirements.

  • GSPR & Technical Documentation
  • STED Preparation & Review
  • Clinical Evaluation Reports (CER)
  • Risk Management Files
  • DHF / Design Control
  • Software V&V Documentation
  • Labeling & IFU Review
  • Clinical Literature Review
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Product & Process Development

Development support focused on pharmaceutical products, processes, formulation optimization, and technology transfer.

  • Pharmaceutical Product Lifecycle Management
  • Novel & Complex Formulation Development
  • Product & Process Development
  • Process Optimization
  • Technical Documentation Support
  • Scale-Up & Technology Transfer Support
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Risk Management & FMEA

Structured risk management methodologies to identify, evaluate, control, and reduce product and process risks.

  • FMEA Development & Review
  • Risk Analysis
  • Risk Management Plans
  • Process & Product Risk Assessment
  • CAPA Management
  • Complaint Handling Systems
  • E&L Risk Assessment
  • Raw Material Risk Assessment
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Scientific & Research Consulting

Evidence-based scientific expertise supporting research strategy, clinical evaluation, and complex development decisions.

  • Literature Review
  • Scientific Evidence Assessment
  • PubMed & Scientific Database Review
  • Regulatory Literature Search
  • Clinical Evaluation Support
  • R&D Consulting for Pharmaceuticals & Medical Devices
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Post-Market Surveillance

Ongoing safety and performance monitoring to support regulatory compliance throughout the product lifecycle.

  • PMS Strategy & Plans
  • PMCF Strategy
  • PSUR Preparation
  • Complaint Trending
  • MAUDE & Regulatory Database Analysis
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Our Process

From Discovery to Delivery

A structured scientific workflow designed to transform complex research challenges into reliable results.

Step 01

Discovery

We understand your scientific objectives, requirements, challenges, and project scope.

Step 02

Research & Planning

Our scientific team develops a structured research strategy tailored to your objectives.

Step 03

Execution

Research and testing are performed using reliable processes, advanced equipment, and scientific expertise.

Step 04

Validation

Results are carefully analyzed and validated against defined quality and performance requirements.

Step 05

Delivery

We deliver clear results, documentation, and actionable scientific insights.

Trusted by Research Teams

WHO WE SUPPORT

Startups
Medical Device Manufacturers
Pharma & Biotech Institutions
SaMD Developers
CROs
Startups
Medical Device Manufacturers
Pharma & Biotech Institutions
SaMD Developers
CROs

FAQ

Frequently Asked Questions

Find answers to common questions about our pharmaceutical research and scientific services.

Contact Us

Let's Discuss Your Research Goals

Tell us about your project, research requirements, or development challenges. Our team will get back to you.

Start a Conversation

Whether you need regulatory support, research consulting, technical documentation, or product development expertise, we're ready to help.

Email

info@solunistresearch.com

Location

Pune, Maharashtra, India

What happens next?
Submit your enquiry and our team will review your requirements and contact you using the details provided.

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