Regulatory Services
SciKonnect Regulatory Services assists healthcare startups and companies in establishing robust regulatory processes that ensure long-term market access in the United States. By proactively addressing FDA requirements and audit preparedness, we aim to prevent costly and time-consuming remediation efforts later in the product life cycle. Our approach emphasizes raising awareness about critical aspects of FDA audits and developing effective strategies for responding to potential warning letters, ultimately fostering a culture of high quality and regulatory compliance.
Scope of Services
- General FDA regulatory guidance/consulting
- CMC guidance for drug-development and control strategies for both API and finished Drug dosage forms (oral and injectables).
- Guidance for effective interactions with the FDA for the pre-IND, EOP2, pre-NDA meetings, and evaluate data packages for the NDA filing for the market approval.
- Assist in CMC change management after the NDA or ANDA approval (i.e., post-approval life cycle management of drug products).
- Advise how to make the operation process of drug development more intelligent and cost-effective while navigating regulatory requirements.
- Help with FDA inspections, evaluate FDA 483s, and any inquiries related to GMP compliance.
- She is a seasoned professional in regulatory affairs with extensive experience across various roles in the biopharmaceutical industry.
- Currently serving as Senior Director of Regulatory Affairs CMC at BridgeBio since March 2023, Mamta supports ML Bio Solutions and CoA Therapeutics in developing treatments for rare diseases.
- Prior positions include Senior Director of Regulatory Affairs CMC at Celldex Therapeutics, where responsibility encompassed CMC regulatory strategies for monoclonal antibodies and immunomodulators.
- Mamta has also provided strategic oversight as a Senior Technical Advisor for a USAID global program at US Pharmacopeia and served as Executive in Residence at Columbia Technology Ventures.
- Currently, she is serving as regulatory advisor for Berkeley Skydeck program for early start-up programs.
- A long tenure at the FDA involved roles such as Senior CMC Policy Advisor and CMC Team Lead, while earlier career stages included positions at the National Institutes of Health and various postdoctoral research roles.
- Educational credentials include a PhD in Analytical Chemistry from the Indian Institute of Technology, Delhi, and advanced degrees in Chemistry and Chemical Engineering from Delhi University and Tokyo Institute of Technology.
– She is a seasoned professional in regulatory affairs with extensive experience across various roles in the biopharmaceutical industry.
– Currently serving as Senior Director of Regulatory Affairs CMC at BridgeBio since March 2023, Mamta supports ML Bio Solutions and CoA Therapeutics in developing treatments for rare diseases.
– Prior positions include Senior Director of Regulatory Affairs CMC at Celldex Therapeutics,
where responsibility encompassed CMC regulatory strategies for monoclonal antibodies and immunomodulators.
– Mamta has also provided strategic oversight as a Senior Technical Advisor for a USAID global program at US Pharmacopeia and served as Executive in Residence at Columbia Technology Ventures.
– Currently, she is serving as regulatory advisor for Berkeley Skydeck program for early
start-up programs.
– A long tenure at the FDA involved roles such as Senior CMC Policy Advisor and CMC Team Lead, while earlier career stages included positions at the National Institutes of Health and various postdoctoral research roles.
– Educational credentials include a PhD in Analytical Chemistry from the Indian Institute of Technology, Delhi, and advanced degrees in Chemistry and Chemical Engineering from Delhi University and Tokyo Institute of Technology.
Why you should choose us?
- 20+ years as Senior Regulatory Advisor at FDA
- Provide CMC guidance for drug-development and control strategies for both API and finished Drug dosage forms (oral and injectables).
- Provide guidance for interactions with the FDA for the pre-IND, EOP2, pre-NDA meetings, and evaluate data packages for the NDA filing for the market approval.
- Assist in CMC change management after the NDA or ANDA approval (i.e., post-approval life cycle management of drug products).
- Advise how to make the operation process of drug development more intelligent and cost-effective while navigating regulatory requirements.
- Dr. Mamta has also conducted foreign inspections during her tenure at the FDA (including 12 inspections in India) and can help in preparing for FDA inspections, evaluate FDA 483s, and any inquiries related to GMP compliance.
– 20+ years as Senior Regulatory Advisor at FDA
– Provide CMC guidance for drug-development and control strategies for both API and finished Drug dosage forms (oral and injectables).
– Provide guidance for interactions with the FDA for the pre-IND, EOP2, pre-NDA meetings, and evaluate data packages for the NDA filing for the market approval.
– Assist in CMC change management after the NDA or ANDA approval (i.e., post-approval life cycle management of drug products).
– Advise how to make the operation process of drug development more intelligent and cost-effective while navigating regulatory requirements.
– Dr. Mamta has also conducted foreign inspections during her tenure at the FDA (including 12 inspections in India) and can help in preparing for FDA inspections, evaluate FDA 483s, and any inquiries related to GMP compliance.
Any direct queries to Consultants will not be entertained.
Send your queries to scikonnect@gmail.com