Trusted Since 2000 • 1150+ Clients • Pan-India Presence

Navigate India's Regulatory Landscape with Confidence

ACPL is India's premier regulatory affairs consultancy — guiding pharmaceutical, medical device, food, and cosmetic companies through CDSCO, FSSAI, BIS, and 15+ regulatory frameworks. From first filing to market launch.

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ISO 9001:2015 Certified
Top 10 Regulatory Consultants in Asia
Pharmaceutical regulatory compliance and quality assurance
25+ Years of Excellence
Product Verticals

Industries We Serve

From pharmaceuticals to food products, we provide end-to-end regulatory support across every major product category in India.

Medical Devices

CDSCO registration, import licenses, and market authorization for Class A–D devices.

Drugs & Pharmaceuticals

Drug registration, manufacturing licenses, clinical trial approvals through CDSCO.

In-Vitro Diagnostics

IVD product registration and compliance under India's evolving IVDR framework.

Biologicals

Regulatory pathways for vaccines, blood products, and biosimilars.

Cosmetics

CDSCO cosmetic registration, import licenses, and cosmetovigilance compliance.

Food Products

FSSAI licensing, food safety compliance, labeling regulations, and import clearance.

Agrochemicals

Registration of insecticides, pesticides, and home care products under CIB&RC.

Home Products

BIS certification, Legal Metrology compliance, and EPR registration for consumer products.

Trusted by 1,150+ Clients Worldwide

What We Do

Comprehensive Regulatory Solutions

Three pillars of expertise that cover the full lifecycle of regulatory compliance in India.

Regulatory affairs documentation and compliance
Core Capability

Regulatory Affairs & Licensing

End-to-end regulatory support across 15+ Indian regulatory bodies including CDSCO, FSSAI, BIS, DGFT, WPC, and more. We handle product registration, manufacturing licenses, import permits, and ongoing compliance — so you can focus on your business.

  • CDSCO drug & device registration
  • FSSAI food business licensing
  • BIS product certification
  • Import/export permits (DGFT, SIP)
  • Legal Metrology & EPR compliance
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Pharmacovigilance and drug safety monitoring
Safety & Compliance

Pharmacovigilance & Vigilance Services

Comprehensive post-market surveillance and safety monitoring services. Our vigilance teams ensure your products maintain compliance throughout their lifecycle — covering drugs, devices, cosmetics, and food products.

  • Pharmacovigilance (drug safety monitoring)
  • Materiovigilance (medical device reporting)
  • Cosmetovigilance & food safety vigilance
  • Adverse event reporting & PSUR management
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Clinical trials and laboratory research
Clinical Development

Clinical Trials & Field Studies

From protocol development to ICMR/DCGI approvals, we manage the full clinical trial lifecycle in India. Our team navigates the regulatory requirements so your studies run on time and within compliance.

  • Clinical trial regulatory approvals
  • ICMR & Ethics Committee coordination
  • Field safety trials for agrochemicals
  • Post-market clinical follow-up (PMCF)
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Clients Served
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Projects Delivered
Compliance Partners

Regulatory Bodies We Work With

CDSCO
CDSCO Central Drugs Standard Control Organization
FSSAI
FSSAI Food Safety and Standards Authority of India
BIS
BIS Bureau of Indian Standards
DGFT
DGFT Directorate General of Foreign Trade
WPC
WPC Wireless Planning & Coordination
CIB&RC
CIB&RC Central Insecticides Board
PESO
PESO Petroleum and Explosives Safety Organisation
LMPC
LMPC Legal Metrology
ISO 9001:2015 Certified Quality Management
About ACPL

India's Most Trusted Regulatory Partner

Accredited Consultants Pvt. Ltd. (ACPL), the flagship company of the ACPL Group, is one of India's leading regulatory affairs consultancies. With over 25 years of experience and a team of 18+ domain experts, we've helped more than 1,150 clients bring safe, compliant products to market.

Recognised among the Top 10 Most Promising Medical Device and Pharmaceutical Regulatory Consultants in Asia 2023 by Asia Business Outlook Magazine, ACPL combines deep regulatory knowledge with a client-first approach that delivers results.

  • 25+ years navigating Indian regulatory frameworks
  • 2,700+ projects across pharma, medical devices, food, and cosmetics
  • Pan-India presence with a team of senior regulatory professionals
  • Trusted by multinationals, SMEs, and startups entering India
Learn More About ACPL
ACPL team — regulatory affairs professionals

Top 10 in Asia

Medical Device & Pharmaceutical Regulatory Consultants — Asia Business Outlook Magazine, 2023

The ACPL Group of Companies

  • ACPL (Flagship Consultancy)
  • Elete Biotech
  • PharmXL
  • Accredited Logistics
  • MedTech Devices
  • TopFlow
  • Pharma Regulatory Institute
Client Testimonials

Trusted by Industry Leaders Across India

ACPL's team guided us through the entire CDSCO registration process for our medical device portfolio. Their deep knowledge of regulatory requirements and proactive communication made what could have been an overwhelming process remarkably smooth. We secured all approvals ahead of schedule.

R
Rajesh Kapoor VP Regulatory Affairs, MedTech Solutions Pvt. Ltd.

We engaged ACPL for FSSAI licensing across multiple product categories. Their expertise in navigating the nuances of food safety regulations in India is unmatched. They didn't just handle the paperwork — they helped us restructure our compliance strategy for long-term success.

D
Dr. Priya Sharma Director of Quality, NutriCare Laboratories

As a European medical device manufacturer entering India for the first time, we needed a partner who understood both the regulatory landscape and the business environment. ACPL delivered on both fronts. Their India Entry Strategy service saved us months of trial and error.

S
Stefan Weber Head of International Markets, Weber Medical GmbH

Ready to Navigate India's Regulatory Framework?

Whether you're launching a new product or expanding into India, our team of 18+ regulatory experts is ready to guide you every step of the way.

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Press

Recognition & Awards

2023

Top 10 Most Promising Medical Device and Pharmaceutical Regulatory Consultants in Asia 2023

Asia Business Outlook Magazine

ACPL was recognized among the top regulatory consultancies across the Asia-Pacific region for its deep domain expertise, client-first approach, and consistent track record across pharmaceuticals, medical devices, and allied healthcare sectors.

Insights

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