A specialist regulatory consulting firm delivering deep remediation, inspection readiness, and end-to-end cGMP compliance solutions for leading pharmaceutical companies across India and globally.
Kotis Consultancy Services (KCS), established in 2012, is a specialist USFDA compliance and cGMP consulting firm with deep remediation and inspection readiness expertise. We help pharmaceutical companies navigate complex compliance challenges and ensure adherence to the highest regulatory standards.
With a team of experienced Subject Matter Experts across quality assurance, regulatory affairs, manufacturing, validation, analytical R&D, and quality control, we deliver customized solutions for FDA compliance remediation. Our team is experienced in collaborating with top USA GMP consultancy firms to address cGMP concerns, QMS-related investigations, ANDA reviews, and Warning Letter responses.
We perform thorough audits to identify gaps in processes and systems, providing detailed corrective action plans. Our experts collaborate with client teams to implement improvements that align with FDA guidelines — minimizing the risk of inspection failures, product recalls, or penalties.
Senior SMEs with deep USFDA inspection experience
USFDA Approved Sites — 65+ Third Party cGMP Audits Completed
| # | Company / USFDA Site | Period | Services Provided |
|---|---|---|---|
| 01 | Famycare / Jai Pharma / Mylan | 2014–2018 | cGMP Audits, QMS Review, FDA 483 Responses |
| 02 | Srikrishna Pharma | 2017–2020 | cGMP Trainings, Lab Systems GAP Audit |
| 03 | Unimark Remedies | 2017–2019 | FDA Warning Letter Remediation |
| 04 | Sidmark – Dehradun | 2017 | cGMP Trainings, Lab Systems GAP Audit |
| 05 | Salicylates & Chemicals – Hyderabad | 2017 | cGMP Trainings, Third Party Audits, FDA 483 Support |
| 06 | IPCA – Indore | 2018 | USFDA Warning Letter Remediation |
| 07 | Jubilant – Mysore & Roorkee | 2018–2023 | USFDA Warning Letter Remediation |
| 08 | Wockhardt – Aurangabad | 2019 | Third Party Audit for USFDA Commitment |
| 09 | Sun Pharma – Mohali/Chandigarh | 2019–2023 | Third Party Audit, FDA 483 Response Support |
| 10 | Lupin – Tarapur & Mandideep | 2020 & 2023 | USFDA Warning Letter Remediation |
| 11 | Aarti Drugs – Biosar, Mumbai | 2019–2024 | USFDA Warning Letter Remediation |
| 12 | Mac-Chem India – Mumbai | 2018–Ongoing | Third Party Audit, FDA 483 Response Support |
| 13 | Calyx Chemical & Pharma – Mumbai | 2018 | FDA Warning Letter Remediation |
| 14 | Encube Ethicals – Goa | 2020, 2024, 2025 | cGMP Trainings, Lab Systems GAP Audit |
| 15 | Intas – Ahmedabad | 2023–Ongoing | Batch Certification, FDA Warning Letter Remediation |
| 16 | AET Labs – Hyderabad | 2018–2022 | Third Party Audits, FDA 483 Response Support |
| 17 | Pinnacle Life Sciences – Baddi | 2019–Ongoing | cGMP Audits, QMS Review, FDA 483 Responses |
| 18 | Graviti Pharma – Hyderabad | 2022–Ongoing | cGMP Audits, QMS Review, USFDA Readiness |
| 19 | Hetero – Unit 9, Nakkapally | 2025–Ongoing | USFDA 483 Response, cGMP Assessments |
| 20 | Unexo Life – Delhi | 2024–Ongoing | USFDA Warning Letter Remediation |
| 21 | Granules India – Hyderabad | 2026 | USFDA Warning Letter Remediation |
Download or view our complete company profile document covering our services, track record, team expertise, and client engagements.
Whether you're facing an FDA inspection, dealing with a Warning Letter, or need a comprehensive cGMP gap assessment — our team of expert SMEs is ready to help.