Ramakrishna K
CMC Regulatory Affairs Expert specializing in Drug Master Files (DMF) submissions to USFDA, EU, and global authorities
CMC Regulatory Affairs professional with over 11 years of experience in pharmaceutical regulatory submissions. Specializes in compilation, preparation and submission of Drug Master Files (DMFs) in accordance with filing requirements of Regulatory Authorities including USFDA, EU, EDQM, TGA-Australia, TPD-Canada, WHO, KFDA, Russia, China & ROW countries. Expert in preparation of applicant part DMFs and technical packages to customers. Has knowledge in submission of DMFs in eCTD and NeeS formats using e-Tool LORENZ. Experienced in review of Change control documents for Regulatory impact and document submission for licensing activity (for Manufacturing & Testing) at drug control authority. Skilled in issuance of Letter of Access (LOA's) and CEPs to respective customers.
About
CMC Regulatory Affairs professional with over 11 years of experience in pharmaceutical regulatory submissions. Specializes in compilation, preparation and submission of Drug Master Files (DMFs) in accordance with filing requirements of Regulatory Authorities including USFDA, EU, EDQM, TGA-Australia, TPD-Canada, WHO, KFDA, Russia, China & ROW countries. Expert in preparation of applicant part DMFs and technical packages to customers. Has knowledge in submission of DMFs in eCTD and NeeS formats using e-Tool LORENZ. Experienced in review of Change control documents for Regulatory impact and document submission for licensing activity (for Manufacturing & Testing) at drug control authority. Skilled in issuance of Letter of Access (LOA's) and CEPs to respective customers.
Additional information
### **Additional information**
- **Type:** independent
- **Company:** Neuland Laboratories Limited
- **Years of experience:** 0
- **Regions served:** US, EU, APAC, MEA, CA, LATAM
- **Client types:** sme, startup
- **Location:** Other (Telangana)
- **Availability:** available_now
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### **Cruxi analysis**
- **Strength summary:** With over 11 years of dedicated regulatory experience, Ramakrishna K offers profound expertise in Chemistry, Manufacturing, and Controls (CMC) and Drug Master File (DMF) submissions. While rooted in the pharmaceutical sector, this skillset is uniquely valuable for medtech companies developing combination products, such as drug-eluting stents or pre-filled delivery systems. His extensive track record of successful submissions to a wide array of global authorities—including the USFDA, EU (EDQM), and Health Canada—demonstrates a mastery of complex international regulatory landscapes. This deep knowledge of API regulatory affairs and quality systems, including change control impact analysis, provides a critical and often hard-to-find competency for medtech firms navigating the dual regulatory requirements of device and drug components.
- **Unique value:** Ramakrishna's unique value proposition for medtech companies is his specialized mastery of pharmaceutical CMC regulatory affairs, bridging the critical gap between drug and device regulations. He provides the focused expertise needed to navigate the complex drug component requirements for combination products, a niche skill set that is indispensable for ensuring successful submissions to the FDA and global agencies.
- **Ideal projects:** The perfect client for Ramakrishna is a startup or SME medtech company developing a combination product that requires a Drug Master File (DMF) or significant CMC documentation. This includes projects involving drug-coated devices, biologic-device combinations, or advanced drug delivery systems. He is ideally engaged by companies preparing for global market entry, leveraging his vast experience with submissions in the US, EU, Canada, and APAC regions. The ideal project would involve authoring the applicant's part of a DMF, preparing technical packages for partners, and managing the regulatory lifecycle of the drug component, ensuring seamless integration with the overall device submission strategy.
- **Last analyzed:** Mon Dec 29 2025 19:59:00 GMT-0500 (Eastern Standard Time)
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### **Qualifications & scope**
- **Submission types:** international, qms
- **Regulatory pathways:** q_sub, post_market
---
- **Type:** independent
- **Company:** Neuland Laboratories Limited
- **Years of experience:** 0
- **Regions served:** US, EU, APAC, MEA, CA, LATAM
- **Client types:** sme, startup
- **Location:** Other (Telangana)
- **Availability:** available_now
---
### **Cruxi analysis**
- **Strength summary:** With over 11 years of dedicated regulatory experience, Ramakrishna K offers profound expertise in Chemistry, Manufacturing, and Controls (CMC) and Drug Master File (DMF) submissions. While rooted in the pharmaceutical sector, this skillset is uniquely valuable for medtech companies developing combination products, such as drug-eluting stents or pre-filled delivery systems. His extensive track record of successful submissions to a wide array of global authorities—including the USFDA, EU (EDQM), and Health Canada—demonstrates a mastery of complex international regulatory landscapes. This deep knowledge of API regulatory affairs and quality systems, including change control impact analysis, provides a critical and often hard-to-find competency for medtech firms navigating the dual regulatory requirements of device and drug components.
- **Unique value:** Ramakrishna's unique value proposition for medtech companies is his specialized mastery of pharmaceutical CMC regulatory affairs, bridging the critical gap between drug and device regulations. He provides the focused expertise needed to navigate the complex drug component requirements for combination products, a niche skill set that is indispensable for ensuring successful submissions to the FDA and global agencies.
- **Ideal projects:** The perfect client for Ramakrishna is a startup or SME medtech company developing a combination product that requires a Drug Master File (DMF) or significant CMC documentation. This includes projects involving drug-coated devices, biologic-device combinations, or advanced drug delivery systems. He is ideally engaged by companies preparing for global market entry, leveraging his vast experience with submissions in the US, EU, Canada, and APAC regions. The ideal project would involve authoring the applicant's part of a DMF, preparing technical packages for partners, and managing the regulatory lifecycle of the drug component, ensuring seamless integration with the overall device submission strategy.
- **Last analyzed:** Mon Dec 29 2025 19:59:00 GMT-0500 (Eastern Standard Time)
---
### **Qualifications & scope**
- **Submission types:** international, qms
- **Regulatory pathways:** q_sub, post_market
---
Key Highlights
- With over 11 years of dedicated regulatory experience, Ramakrishna K offers profound expertise in Chemistry, Manufacturing, and Controls (CMC) and Drug Master File (DMF) submissions. While rooted in the pharmaceutical sector, this skillset is uniquely valuable for medtech companies developing combination products, such as drug-eluting stents or pre-filled delivery systems. His extensive track record of successful submissions to a wide array of global authorities—including the USFDA, EU (EDQM), a
- Ramakrishna's unique value proposition for medtech companies is his specialized mastery of pharmaceutical CMC regulatory affairs, bridging the critical gap between drug and device regulations. He provides the focused expertise needed to navigate the complex drug component requirements for combination products, a niche skill set that is indispensable for ensuring successful submissions to the FDA and global agencies.
Buyer Snapshot
Best for
- The perfect client for Ramakrishna is a startup or SME medtech company developing a combination product that requires a Drug Master File (DMF) or significant CMC documentation. This includes projects involving drug-coated devices, biologic-device combinations, or advanced drug delivery systems. He is ideally engaged by companies preparing for global market entry, leveraging his vast experience wit
HQ:
Other
Languages:
English
Status:
claimed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
510(k) RTA Remediation / Refuse-to-Accept Fix, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C)
Pathways Supported:
Pre-Sub / Q-Sub
Device Types Supported:
Medical device
Supports Rta Remediation:
Yes
Years Experience:
0
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Accepting New Clients:
Yes
