Pharma & Biotech Products and Services — India 2026
Complete Products and Services for Pharma & Biotech Companies in India
Traccglobal delivers end-to-end pharma and biotech products and services — from CDSCO registration and WHO GMP certification to ISO 13485, FDA 510(k), CE marking, and full turnkey pharmaceutical project management. We simplify regulatory complexity so you can focus on what matters — bringing your product to market faster.
200+ Successful Projects
15+ Countries Served
98% Client Satisfaction
10+ Years Experience
What are Pharma & Biotech Products and Services?
Pharma and biotech products and services include the full spectrum of regulatory, quality, and operational support that pharmaceutical and biotechnology companies need to develop, manufacture, and commercialize their products. In India, this covers CDSCO medical device registration, WHO GMP certification, ISO 13485 quality management system, FDA 510(k) consulting, CE marking, drug manufacturing licenses, and turnkey pharmaceutical project setup. Traccglobal is a Delhi-based regulatory consultancy that provides all these services under one roof, helping both Indian and foreign pharma companies navigate India’s complex regulatory landscape and achieve global compliance efficiently.
Why India is the Global Hub for Pharma & Biotech in 2026
India is the world’s third-largest pharmaceutical producer by volume and is home to the highest number of US FDA-approved plants outside the United States. The Indian pharma market is projected to reach $130 billion by 2030. For any pharma or biotech company looking to manufacture, import, or distribute products in India — or export from India to global markets — understanding CDSCO and other regulatory frameworks is not optional. It is the foundation of your entire business.
65B+
India pharma market size (2025)
3rd Largest
Global pharma producer by volume
700+
US FDA approved plants in India
$130B
Projected market size by 2030
Comprehensive Pharma & Biotech Products and Services
Whether you are a startup launching your first medical device or an established pharmaceutical company expanding to new markets, Traccglobal’s pharma and biotech products and services cover every stage of your regulatory journey.
CDSCO Registration & Licensing
Get your medical device or pharmaceutical product registered with CDSCO without delays. We handle Form MD-15 (import license), Form MD-5/MD-9 (manufacturing license), technical dossiers, and liaison with regulatory officers on your behalf.
WHO GMP Certification
WHO GMP certification is essential for pharmaceutical export from India. Our pharma and biotech products and services team prepares all documentation, conducts mock audits, and ensures your manufacturing facility meets WHO-GMP standards for regulated markets.
ISO 13485 Quality Management System
ISO 13485 is the international standard for QMS in medical device manufacturing. Traccglobal builds your entire quality management system from scratch — SOPs, risk management (ISO 14971), CAPA, internal audit programs — and prepares you for certification audits.
FDA 510(k) Consulting for Medical Devices
Planning to enter the US market? Our pharma and biotech products and services include end-to-end FDA 510(k) preparation — predicate device search, substantial equivalence analysis, performance testing, and submission management. We have helped Indian companies achieve US FDA clearance successfully.
CE Marking for Medical Devices
CE marking opens the European Union market for your medical device. Traccglobal assists with technical file preparation, clinical evaluation, PMCF planning, Declaration of Conformity, and notified body coordination for CE marking under EU MDR and IVDR regulations.
Turnkey Pharmaceutical Project Consultancy
Setting up a new pharma or biotech manufacturing facility in India? Our turnkey project services cover feasibility studies, detailed project reports (DPR), facility layout design, equipment selection, cleanroom design, validation documentation, and complete license acquisition — all from a single point of contact.
Schedule M & Drug Manufacturing License
India's revised Schedule M (2024) sets strict GMP requirements for pharmaceutical manufacturers. Traccglobal ensures your facility is fully compliant with Schedule M, assists with drug manufacturing license applications, and prepares you for state drug controller inspections.
Design & Development for Medical Devices
From concept to clinical evaluation, our design and development pharma and biotech products and services cover Design History File (DHF) preparation, risk management files, design verification and validation, and software documentation for SaMD as per IEC 62304 requirements.
Multi-Country Regulatory Submissions
Expand your market reach globally. Traccglobal manages regulatory submissions across Saudi Arabia (SFDA), UK (UKCA), Russia, and other emerging markets. Our team understands local regulatory requirements, documentation formats, and submission portals for each jurisdiction.
Our Process
How Traccglobal Delivers Pharma & Biotech Products and Services
Our structured engagement model ensures you always know where your project stands. From the first call to final approval — we own the process.
Free Consultation
We understand your product, target market, and regulatory requirements in a detailed discovery call.
Gap Analysis
Our experts audit your existing documentation and facility to identify compliance gaps with a clear action plan.
Documentation
We prepare all technical files, SOPs, quality manuals, and submission dossiers to the required regulatory standard.
Submission & Liaison
We submit applications, coordinate with regulatory authorities, and respond to queries on your behalf.
Approval & Post-Market
We support you through the approval stage and provide ongoing post-market surveillance and compliance maintenance.
How Our Pharma & Biotech Products and Services Compare
Not all regulatory consultancies are the same. Here is why pharma and biotech companies across India choose Traccglobal over others.
| Service Feature | Traccglobal | Generic Consultants | International Firms |
|---|---|---|---|
| India-specific regulatory expertise (CDSCO, Schedule M) | ✔ Deep Expertise | Partial | Limited |
| Multi-country submissions (US FDA, CE, SFDA, UKCA) | ✔ All Markets | ✘ | Costly |
| Turnkey project management (facility to license) | ✔ Full Turnkey | ✘ | ✘ |
| Dedicated project manager per client | ✔ Always | Rarely | Sometimes |
| ISO 13485 + CDSCO dual compliance support | ✔ Integrated | Separate | Separate |
| India-based team with local regulatory network | ✔ Delhi NCR | Varies | ✘ |
| Transparent pricing with no hidden fees | ✔ Always | Sometimes | Rarely |
Real Case Studies: Pharma & Biotech Products and Services in Action
Our pharma and biotech products and services are not theoretical. Here are real project outcomes that demonstrate Traccglobal’s expertise and trustworthiness.
Class B Medical Device — CDSCO Import License in 90 Days
A South Korean medical device manufacturer needed CDSCO import license for a diagnostic imaging device. Their previous consultant had failed twice due to incomplete technical documentation. Traccglobal took over, conducted a full document gap analysis, rebuilt the technical dossier per MDR 2017, and managed the complete submission and CDSCO liaison.
Result: Import license approved in 90 days — first attempt, zero queries from CDSCO
Pharma Startup — Turnkey Plant Setup & WHO GMP Certification
A first-generation pharma entrepreneur in Haryana approached Traccglobal to set up a tablet manufacturing facility from scratch. We provided the detailed project report, facility layout, equipment selection, cleanroom design, Schedule M documentation, and prepared the facility for WHO GMP audit — all within a single engagement.
Result: WHO GMP certified within 18 months — facility now exporting to 3 African markets
IVD Company — ISO 13485 Certification & CE Marking for EU Market
A Pune-based in-vitro diagnostic company wanted to expand to European markets. They had no QMS in place. Traccglobal built their entire ISO 13485 QMS, prepared the technical file for CE marking under EU IVDR, and coordinated with a notified body for certification — giving them market access to 27 EU countries.
Result: CE marking achieved in 14 months — now selling in Germany and France
US FDA 510(k) Clearance for Indian Orthopedic Device Manufacturer
An Ahmedabad-based orthopedic implant manufacturer wanted 510(k) clearance for their bone screw system. Traccglobal identified the right predicate device, prepared the substantial equivalence argument, managed performance testing coordination, and submitted the complete 510(k) package to US FDA.
Result: 510(k) clearance obtained in 9 months — product now distributed across 5 US states
Understanding Pharma & Biotech Products and Services in India's 2026 Regulatory Landscape
India’s pharma and biotech sector has undergone significant regulatory evolution in 2024–2026. The revised Schedule M, updated CDSCO guidelines for Class C and D devices, and India’s increasing alignment with ICH and WHO standards mean that regulatory compliance has become more demanding — and more valuable — than ever before.
For pharmaceutical companies, the path to market now requires not just a manufacturing license, but a fully functional Quality Management System, validated manufacturing processes, documented design history, and robust post-market surveillance. This is where end-to-end pharma and biotech products and services from an experienced consultancy like Traccglobal make a critical difference.
Biotech companies face an additional layer of complexity — whether dealing with biosimilars, biologics, or in-vitro diagnostics (IVDs), the regulatory pathway involves CDSCO’s New Drug and Clinical Trials Rules (NDCTR) alongside ISO 15189 for laboratory compliance and ISO 13485 for device manufacturers. Navigating this landscape without expert guidance often results in costly delays and application rejections.
India’s push under Atmanirbhar Bharat has also accelerated domestic medical device manufacturing, with the Production Linked Incentive (PLI) scheme providing financial support to medical device companies. However, qualifying for PLI requires demonstrating compliance with CDSCO and quality standards — which Traccglobal helps clients achieve as part of our integrated pharma and biotech products and services.
Looking ahead to 2026 and beyond, AI and digital health tools are creating new regulatory categories in India. Software as a Medical Device (SaMD) classification, IEC 62304 compliance for medical device software, and CDSCO’s emerging digital health guidelines are areas where Traccglobal‘s team provides specialized guidance — keeping your products compliant with both today’s standards and tomorrow’s requirements.
People Also Ask — Pharma & Biotech Products and Services
These are the most searched questions about pharma and biotech products and services in India, answered by Traccglobal’s regulatory experts.
What pharma and biotech products and services does Traccglobal offer in India?
Traccglobal offers a comprehensive range of pharma and biotech products and services including CDSCO medical device registration, ISO 13485 QMS certification, WHO GMP certification, FDA 510(k) consulting, CE marking for EU markets, Schedule M compliance, drug manufacturing licenses, turnkey pharmaceutical project management, design and development support for medical devices, and multi-country regulatory submissions. All services are delivered by experienced regulatory professionals based in Delhi NCR, India.
How long does CDSCO medical device registration take in India?
CDSCO medical device registration typically takes 3–12 months depending on the device class. Class A and B devices generally get approved in 3–6 months, while Class C and D devices may take 6–12 months due to stricter technical review requirements. Incomplete documentation is the most common cause of delays. Traccglobal’s expert team ensures error-free first-time submissions, achieving an average approval time of 90 days for Class B devices.
Is WHO GMP certification mandatory for pharmaceutical export from India?
Yes, WHO GMP certification is mandatory for pharmaceutical companies in India that export products to regulated markets in Africa, Southeast Asia, and many other regions. It proves that your manufacturing facility meets international Good Manufacturing Practice standards. Traccglobal helps you prepare complete WHO GMP documentation, conduct mock inspections, and achieve certification from the Central Drugs Standard Control Organization or state drug controllers.
What is the cost of pharmaceutical regulatory consultancy in India?
The cost of pharma regulatory consultancy in India depends on the scope — a single CDSCO import license application costs differently from a full turnkey project or multi-country submissions. Traccglobal offers transparent, project-based pricing with no hidden fees. Contact us for a free initial consultation where we assess your requirements and provide a detailed quote tailored to your specific project.
Can a foreign pharma company get CDSCO registration without an Indian agent?
No. As per India’s Medical Devices Rules 2017, foreign pharmaceutical and medical device companies must appoint an authorized Indian agent or authorized representative to apply for CDSCO registration. The Indian agent is legally responsible for regulatory compliance in India. Traccglobal acts as an authorized Indian agent for foreign companies, managing the entire CDSCO submission and post-approval compliance on their behalf.
What documents are required for ISO 13485 certification?
ISO 13485 certification for medical devices requires a Quality Manual, Scope of QMS, documented SOPs covering design and development, purchasing, production, complaint handling, and CAPA. You also need risk management documentation per ISO 14971, internal audit records, management review minutes, and calibration/maintenance records. Traccglobal prepares all ISO 13485 documentation aligned with both international standards and CDSCO requirements, ensuring a smooth certification audit.
What is Schedule M compliance for pharmaceutical manufacturers in India?
Schedule M is a schedule under India’s Drugs and Cosmetics Act that defines Good Manufacturing Practices (GMP) for pharmaceutical manufacturing facilities. India revised Schedule M in 2023 to align with WHO-GMP standards, making it mandatory for all licensed pharmaceutical manufacturers. Compliance requires proper facility design, equipment qualification, process validation, quality control systems, and trained personnel. Traccglobal helps pharma companies achieve and maintain Schedule M compliance efficiently.
Ready to Get Your Pharma or Biotech Product Approved in India?
Speak to a Traccglobal regulatory expert today. Free consultation. No commitment. Just clear, honest advice on the fastest path to approval for your specific product.