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:

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 CDSCO

  • Regulatory Dispute Resolution
    Handling legal issues related to Schedule M, GCP, GLP, and GMP violations

  • Compliance 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

Pharmacovigilance
Comprehensive pharmacovigilance services provided, ensuring drug safety and compliance with regulatory requirements globally.
QMS and GMP Documentation
Establishing quality management policies that define the organization's overall approach to achieving quality excellence.
Detailed Engineering
Leveraging 23+ years of experience to facilitate project design, execution, and management for greenfield developments.
Regulatory Support
Offering expert regulatory advice and strategies to navigate complex compliance requirements effectively.
Training
Training includes audio and video classroom sessions to comprehensively understand key concepts and methodologies.
Intellectual Property Rights
Delivering prior art searches, patent specification drafting, filing, and prosecution services for patent applications.
Formulation, Analytical development, and Stability
Supporting analytical and product development needs through our experienced associate company partners.
Qualification & Validation
Offering onsite/offsite qualification services for pharmaceutical facilities, cleanrooms, equipment, and laboratory instruments.
Academic Services
Organizing panel discussions featuring industry leaders on topics like drug development pipelines or emerging pharmaceutical technologies.
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 CDSCO Regulatory Dispute Resolution Handling legal issues related to Schedule M, GCP, GLP, and GMP violations Compliance Advisory Clear legal advice on labelling, marketing, and advertising compliance

Our Clients

Success Stories

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Contact at Suktas