Hyderabad, Telangana

About us

Who We Are

We are a team of experienced pharma professionals with deep expertise across API, R&D, Quality Assurance, Regulatory Affairs, Audits, and Technology Transfer.
Qualisyn was founded to bridge a common gap in the industry: strong scientific capability without structured compliance, or compliance without practical execution. We bring both together.
Our work spans regulatory compliance, quality management systems, documentation, audit preparedness, process development, optimization, scale-up, and IPR-focused innovation. We help organizations streamline operations, reduce regulatory risk, and build systems that stand up to real inspections.

Our Vision

To remain a trusted partner enabling pharmaceutical MSMEs to go global by harnessing innovation, technology, and compliance to produce safe and efficacious drugs.

Our Mission

To empower pharma and API manufacturers through strategic consulting, regulatory expertise, and value-driven solutions that elevate their global competitiveness while upholding the highest standards of integrity, quality, and compliance.

Our Values

  • Integrity First – We do what is right, even when no one is watching.
  • Excellence in Compliance - Quality and regulatory discipline are non-negotiable.
  • Empowerment Through Knowledge - We enable teams, not just systems.
  • Innovation with Purpose - Science backed by real-world application.
  • Partnership for Growth- Long-term relationships over short-term wins.

Leadership Team

Sriparna

Sriparna - Partner

A seasoned compliance and quality leader with two decades of experience at a leading global technology company, she brings deep expertise in CSV, building robust systems, driving process excellence, and ensuring alignment with stringent regulatory expectations.

Her Strategic Edge

  • Expertise in Quality Based Process Design
    She ensures watertight compliance by designing processes that meet the highest regulatory standards.
  • Proven Experience in Digitization & IT Systems
    With extensive hands-on experience, she drives successful implementation of digital solutions and IT systems that enhance efficiency.
  • Innovative, Practical & Cost Conscious Approach
    Her unconventional yet pragmatic perspective delivers solutions that are both effective and financially prudent.
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niranjan gokhale

Dr. Niranjan Gokhale - Partner

Extensive experience in API development, process optimization, audits, regulatory strategy, and a strong understanding & hands-on experience in OLED technologies, helping organizations scale efficiently while maintaining regulatory compliance. He has several patents in his name.

His Strategic Edge

  • Business Acumen That Drives Success
    He translates deep knowledge into tangible business growth and measurable outcomes.
  • Proven Growth Catalyst
    With a track record of helping organizations expand many fold, he brings both vision and execution.
  • Global Access to Innovation
    Through collaborations with internationally acclaimed scientists, he connects businesses to advanced technologies and cutting edge solutions.
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Advisory Team

dr. mukund s chorgade

Dr. Mukund S. Chorghade, Ph. D., D.Sc.
Advisor

Dr. Mukund S. Chorghad is a globally recognized scientist, entrepreneur, and distinguished visiting professor at IIT Bombay. Founder & CSO of THINQ Pharma and Ayurvidya Healthcare Innovations, with pioneering contributions to drug discovery and process chemistry. Fellow of leading international academies and collaborator with top universities worldwide, including Caltech, Harvard, MIT, Cambridge, and University of Illinois Urbana-Champaign. Recipient of multiple “Scientist of the Year” awards, shaping innovation across academia, industry, and healthcare.

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Our Expertise Spans the Full API Lifecycle

synthetic api development
Synthetic API Development
quality assurance systems and gmp compliance
Quality Assurance & GMP Compliance
process development optimization and scale up
Process Development Optimization
regulatory affairs & dossier support
Regulatory Affairs & Dossier support
target product profle
Target Product
Profle
technology transfer packages
Technology Transfer Packages
development quality assurance
Development Quality Assurance
business advisory in a modern setting
Investment Advisory & M&A Support

Scientific Insight | Strategic Impact

Transforming deep scientific expertise into decisive strategies that deliver measurable business results in pharma.

Our Approach

Our approach is rooted in collaboration, innovation, and practicality - working closely with clients to co-create forward-thinking solutions. We focus on delivering real-world, actionable results that drive measurable impact and sustainable success.

Why Choose Us

Choose us for our deep expertise, compliance-first approach, and practical, implementation-focused solutions tailored for pharma MSMEs. With 360° support and a commitment to long-term sustainable results, we ensure you stay audit-ready and growth-driven.

Global Presence

Supporting Clients Across Markets Based in Hyderabad, India, Qualisyn supports clients with ambitions beyond domestic markets. We work with pharmaceutical MSMEs, API manufacturers, and growing organizations preparing for global regulatory submissions, international audits, and market expansion. Our clientele spans diverse product portfolios and regulatory pathways, with a strong focus on long-term

Sustainability & ESG Commitments

Responsible Growth, Built In Sustainability is not an add-on to our consulting. It’s integrated into how we design processes and systems. Our approach emphasizes: • Efficient process design and optimization • Atom economy and waste reduction principles • Regulatory-compliant, environmentally responsible operations • Long-term operational sustainability over short-term fixes We help organizations align compliance, quality, and environmental responsibility into a single, workable framework.