ABOUT
SUKTAS
SUKTAS, a consultancy firm established under the Company Act, 2013 of the Government of India in November 2022, is a leading provider of comprehensive consultancy services. SUKTAS offers global solutions across a diverse range of industries, including Pharmaceuticals, Biopharmaceuticals, Medical Devices, Foods, Beverages, Cosmetics, and Testing Laboratories. Our expertise ensures compliance with the most stringent regulatory requirements.
At SUKTAS, we deliver integrated solutions for all your GMP, Quality, Patent, Regulatory, and Engineering needs. Our services encompass pharmaceutical manufacturing, including API production, oral dosage formulations, injectables, dry powders, specialty chemicals, R&D, pilot plants, and facilities for biopharmaceuticals, and healthcare products including oncology, hormones, and steroids.
We stay at the forefront of technological advancements and regulatory updates in the pharmaceutical industry, ensuring our clients benefit from the latest technologies, machinery, and products. SUKTAS is committed to bridging the gap between your pharmaceutical manufacturing aspirations and their realization, providing a seamless path from vision to execution.
Our end-to-end and handholding services encompass extensive reference to the following standards and guidelines:
- USFDA
- MHRA, EMEA
- WHO
- PIC/S
- ICH
- TGA
- ANVISA
- Health Canada
- Japan MHLW
- DBT, RCGM, IBSE
- ROW / Country-specific Regulations
- ISO 13485/ CE, ISO 17025/ NABL, ISO 9001
- FSSAI

OUR SERVICES
Regulatory Litigation
From Compliance to Courtroom – We’re With You Every Step of the Way
We support pharmaceutical and life sciences companies in navigating regulatory legal challenges. Our services include:
CDSCO Representation
Defending clients against show-cause notices or license cancellations from CDSCORegulatory Dispute Resolution
Handling legal issues related to Schedule M, GCP, GLP, and GMP violationsCompliance Advisory
Clear legal advice on labelling, marketing, and advertising compliance
Real Pain Points We Solve
We understand the common challenges pharma businesses face:
“Received a CDSCO show-cause notice due to inadequate documentation”
“Import license delayed because of compliance errors”
“Drug license suspended over misbranding or labelling issues”
We’ve helped companies handle all these situations and more.
Why Choose Us
Specialized Lawyers with deep knowledge of life sciences and pharmaceutical law
Strong grasp of technical documentation and regulatory processes
We communicate directly with CDSCO on your behalf
Proven track record in successfully representing clients in regulatory hearings
OUR SERVICES
Our Clients











Success Stories
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