Pharmaceutical & API Regulatory Consulting

Precision expertise
for pharmaceutical
compliance

Chokshi Consultancy empowers pharmaceutical companies with robust API development, regulatory compliance, and quality systems — offering audit-ready solutions and tailored guidance.

25+
Years of Industry Experience
3
Core Service Domains
📍 Vadodara, Gujarat, India
📞 +91 94263 94305
hemant.chokshi1974@gmail.com

Trusted expertise built on decades of practice

Led by Hemantkumar A. Chokshi, our consultancy brings deep technical knowledge in pharmaceutical API development and regulatory affairs. We partner with companies of all sizes — from startups to established manufacturers — to navigate complex compliance landscapes with confidence.

🔬
Technical Depth
Hands-on expertise across API synthesis, process development, and analytical methods.
📋
Regulatory Clarity
Clear, accurate documentation for CDSCO, FDA, and international regulatory submissions.
Fast Turnaround
Reliable, responsive support so your operations never stall waiting for answers.
💰
Cost Effective
Expert-level consultancy without the overhead of a large firm.
"

Our goal is simple — to make regulatory compliance and API quality achievable for every pharmaceutical company, regardless of size.

Hemantkumar A. Chokshi
Founder & Principal Consultant
25+
Years
Experience

Our core services

End-to-end support across every stage of pharmaceutical development and compliance.

01

API Development

From early-stage process development through validation and successful technology transfer — we ensure your API is production-ready and fully documented.

  • Process development & optimisation
  • Validation protocols & reports
  • Technology transfer support
  • Troubleshooting & root cause analysis
02

Regulatory Support

Navigate CDSCO and FDA licensing requirements with confidence. We prepare and review all documentation needed for successful regulatory submissions.

  • Form 29 & FDA licensing
  • Drug Master File (DMF) preparation
  • Regulatory strategy & planning
  • Submission review & gap analysis
03

Quality Support

Build and maintain an audit-ready quality system. From SOPs to stability studies, we provide the full foundation your facility needs to stay compliant.

  • Site Master File & SOP writing
  • QMS setup & investigation support
  • Method validation & stability studies
  • Vendor & instrument qualification
  • Monograph evaluation & implementation

The Chokshi difference

We're not a large firm with layers of bureaucracy. We're a focused consultancy where every client receives direct, personal attention from an experienced professional.

📄
Clear, Accurate Documentation
Every report, SOP, and submission is written to be clear, compliant, and audit-ready from day one.
Fast & Reliable Support
We understand that regulatory timelines are tight. Our response time is one of our strongest assets.
🧪
Strong Technical Expertise
Deep scientific knowledge across API chemistry, analytical methods, and quality systems.
💼
Cost-Effective Consultancy
Expert-level guidance at a fraction of the cost of a large consulting firm.
🗺️
End-to-End Guidance
From initial API process design all the way through regulatory approval and ongoing quality maintenance — we are with you at every step of the journey.

Let's start a conversation

Ready to simplify your regulatory journey? Reach out for a free initial consultation. We'll assess your needs and outline how we can help.

📞
Phone
+91 94263 94305
Email
hemant.chokshi1974@gmail.com
📍
Location
Vadodara, Gujarat, India
Send an enquiry