top of page
Dr. Bani
Search


The Value of Clinical Research Consulting Services
In today's fast-paced pharmaceutical landscape, research and development can be a daunting task. Companies face myriad challenges, from...

bani tchekanova
5 days ago3 min read
2 views
0 comments


Navigating Clinical Trial Regulations in the U.S.
Navigating the complex landscape of clinical trial regulations can be daunting for pharmaceutical companies and researchers....

bani tchekanova
Jun 134 min read
5 views
0 comments


Regulatory Submission Management: A Comprehensive Guide
Understanding Regulatory Submission Management Regulatory submission management is a critical aspect of the pharmaceutical industry. It...

bani tchekanova
Mar 312 min read
7 views
0 comments


For Emerging Biotech Firms, Understanding and Navigating the Regulatory Landscape is Crucial
Navigating the complex landscape of drug development requires a keen understanding of regulatory affairs, as these processes are critical...

bani tchekanova
Mar 152 min read
23 views
0 comments


eCDT Module - 3 Key Considerations for Quality Summary
eCDT Triangle The Quality Summary in Module 3 of the electronic Common Technical Document (eCTD) provides a high-level overview of the...

bani tchekanova
Feb 192 min read
19 views
0 comments


FDA Report on AI Use in Regulatory Decision-Making for Drugs and Biological Products
Overview The FDA draft guidance (January 2025) provides recommendations for the use of Artificial Intelligence (AI) in regulatory...

bani tchekanova
Feb 102 min read
12 views
0 comments



bani tchekanova
Feb 90 min read
2 views
0 comments


What is an IND Application?
A short introduction from Dr. Bani, Chief Principal Advisor in Global Clinical Regulatory Affairs at ClinReg Partners. Book your...

bani tchekanova
Jan 251 min read
4 views
0 comments


How Soon Should I get Regulatory Team Involved in Drug Development process ?
A short introduction from Dr. Bani, Chief Principal Advisor in Global Clinical Regulatory Affairs at ClinReg Partners. Book your...

bani tchekanova
Jan 231 min read
2 views
0 comments


What is Clinical Regulatory Affairs?
A short introduction from Dr. Bani, Chief Principal Advisor in Global Clinical Regulatory Affairs at ClinReg Partners. Book your...

bani tchekanova
Jan 211 min read
2 views
0 comments


Navigating the Challenges of eCTD Submissions: What to Look For and How to Overcome Pitfalls
The Electronic Common Technical Document (eCTD) submission process is crucial in the regulatory framework. It facilitates the seamless...

bani tchekanova
Dec 26, 20243 min read
58 views
0 comments


Introducing Dr. Bani Tchekanova's Latest eBook: Top 10 Strategies to Overcome Challenges in Drug Development
In the high-stakes journey of bringing a drug to market, some executives may overlook critical elements that determine success. Dr....

bani tchekanova
Dec 17, 20241 min read
32 views
0 comments


Top 10 Pharma Industry Trends & Innovations for 2025
The pharmaceutical industry is evolving rapidly, driven by technology, regulatory changes, and new patient needs. Here’s a snapshot of...

bani tchekanova
Dec 4, 20242 min read
473 views
0 comments


10 Essential Steps for a Successful FDA Meeting in your drug development journey
Introduction The FDA meeting process is a critical milestone in drug development, offering opportunities to gain regulatory alignment and...

bani tchekanova
Nov 26, 20242 min read
32 views
0 comments


Top 5 Areas to Leverage Expert Clinical Regulatory Affairs Advisor for New Drug Development Companies
Accelerate Your Path to Market with ClinReg Partners At ClinReg Partners, we specialize in guiding emerging pharmaceutical and biotech...

bani tchekanova
Nov 25, 20242 min read
0 views
0 comments


eCTD Consultation and Submission Services for FDA Compliance
eCTD Consultation and Submission Services for FDA Compliance Streamlining Your Path to Regulatory Approval At ClinReg Partners, we...

bani tchekanova
Nov 23, 20242 min read
22 views
0 comments


The Importance of Regulatory Compliance in Pharmacovigilance
Pharmacovigilance is crucial in the pharmaceutical industry. It ensures the safety and efficacy of drugs. This field involves monitoring,...

bani tchekanova
Oct 26, 20243 min read
14 views
0 comments


Role of Clinical Regulatory Affairs in the Drug Development Process
Clinical regulatory affairs play a critical role in the drug development process by ensuring that pharmaceutical products meet regulatory...

bani tchekanova
Aug 1, 20242 min read
14 views
0 comments


WHAT IS CCDS, AND WHEN IS IT NEEDED?
CCDS stands for Core Clinical Data Sheet. It is a document used in the pharmaceutical industry to provide essential information about a...

bani tchekanova
Jul 18, 20242 min read
308 views
0 comments


Artificial Intelligence (AI) is revolutionizing the Pharma industry by accelerating 𝐝𝐫𝐮𝐠 𝐝𝐞𝐯𝐞𝐥𝐨𝐩𝐦𝐞𝐧𝐭 𝐩𝐫𝐨𝐜𝐞𝐬𝐬𝐞𝐬.
Some of the key areas that are making development time reduction possible are: Analyzing vast datasets, improving accuracy and speed....

bani tchekanova
Jun 13, 20241 min read
4 views
0 comments
bottom of page