How we can help you
We provide end to end services to Pharma, MedTech and Cell Gene Therapy Companies from the Research Concept Stage to the Commercialization of the Product/s. Services include Regulatory Affairs, Clinical Study Management, Clinical Data Management, Medical Writing and GxP Audits.
We conduct Early Phase to Late Phase PMS Clinical Studies for Drugs, Devices, Special Therapeutics, Fixed Dose Combinations and AI based Software Applications.
We have the capability to engage right from the concept stage to the clinic stage. We can engage at any stage of the development cycle as maybe required by you. We have experience in wide variety of therapeutic indications and modalities. We possess deep expertise in Cell Gene therapy, Medical Device trials and AI based therapeutic and diagnostic solutions. We can provide expert support across GMP, GLP and GCP. We can leverage our rich network for the benefit of the customer.
Who we are
We are an ISO 9001 : 2015 Certified Full Service CRO possessing deep knowledge and expertise in the field of Clinical Research. We have long standing in the industry of over a decade.
We have worked with the latest cutting research in the Pharma and MedTech Industry including Cell Gene Therapy, AI in Medical Devices and latest Healthcare Solutions. We have worked with Companies Offering Pharma and Diagnostics Solutions in Oncology, Cardiology, Ophthalmology, Dermatology, Hepatology, Hematology and Orthopedics among Others.
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What we do
Clinical Study Management
We manage all phase of clinicals trials including Investigator Led Trials. Our Engagements commence with support for sites selection and conclude with the final CSR. We have robust SOPs and systems to ensure protocol adherence, regulatory and GCP Compliance.
Regulatory Affairs
We provide comprehensive support for Regulatory Affairs including mapping out Regulatory pathways in different geographies and hands-on support for Regulatory Submissions until the final outcome of Applications.
Technical Writing
We specialize in technical writing services focused on clinical, quality, and regulatory documentation crucial for the healthcare and pharmaceutical industries.
Quality Assurance
Nextvel specializes in providing a comprehensive suite of Quality Assurance (QA) Audit services aimed at ensuring compliance with regulatory standards and optimizing operational efficiency spanning across diverse products and therapeutics.
Training
We promote excellence in clinical research through comprehensive training and capacity building programs. Training includes basic and advanced training in Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Clinical Laboratory Practice (GCLP), Regulations to enhance knowledge and skills needed for high-quality, compliant clinical research.
See how we've helped companies like yours
Values
Ethics
We are committed to providing services which conform to the highest Ethical Standards with strict adherence to principles of GCP
Integrity
We believe that Integrity in the workplace is of paramount importance. We aim to be honest, transparent, trustworthy and professional in all our dealings with customers, vendors, partners or colleagues.
Customer focussed
We strive to exceed client expectations through active communication and custom-made solutions.
Our teams work efficiently, ethically, and with integrity for the customers.
Change being constant, we focus on quality and timeliness to adapt to the changes.
Quality
We are focussed on providing the highest quality deliverables through robust Quality Management Systems, Standard Operating Procedures and comprehensive training programs for our personnel
Why choose us
Long standing in the industry for over a decade and a half
Network, Partnership and Collaboration with Investigators, Site Management Organizations, CR Consultants, Therapeutic Experts, Site Coordinators, Resourcing Consultants.
Expertise to Conduct Early Phase to Late Phase PMS Clinical Studies for Drugs, Devices, Special Therapeutics and Fixed Dose Combinations and AI based software applications
We have long term relationships with most of our customer strecthing into several years and we have repeat business from 90% of our existing customers
We are transparent with customers in terms of our charges and expenses and provide cost effective solutions to reduce cost of trials.
Testimonials
I can thoroughly recommend Nextvel. They are a joy to work with, very professional and helpful. They know their stuff and gently but firmly move you through the process. They have helped us get approval for a clinical trial in India at a very difficult time which required hard work, determination, skill and patience. They are extremely professional to deal with and very pleasant. With Nextvel you are in good hands.
Professor Sheila MacNeil BSc (Hons), PhD
Was a delight to work with Nextvel. The team has a problem-solving approach and always goes above and beyond. It never felt like we were chasing regulatory approval alone, it always felt like a team (MTx and Nextvel) working together towards a goal.
MicrobioTx
I wanted to take a moment to express my sincere gratitude for the outstanding support you have provided. Your team’s professionalism, expertise, and dedication have truly made a difference in our experience, and we are thrilled with the results achieved through your guidance.
Please extend our thanks to everyone involved in the project. We look forward to future collaborations and will happily recommend your services to others.
Dr. HV Nagesh
Nextvel provided our ophthalmic surgical laser firm with local knowledge of prospective partner candidate medical facilities, they guided us through the Indian regulatory, they organized, supervised, QA’d and libraried all trial data collected for each participating patient – from recruitment through post-op follow-up, and then they analyzed and assembled the trial results in a comprehensive report ready for peer review and publication. They are a professional, comprehensive quality control operation in complete command of the subject matter and ready to deploy on your behalf . We would not have been successful without them.
Michael Ballad
We are very satisfied with our cooperation
Steffen Gebauer
This is to certify that we have used the Regulatory Affairs and Clinical Research Services of Nextvel Consulting LLP since 2012.
Nextvel led by Ms. Mala Srivastava, Co-founder & Managing Partner, has supported us in obtaining the necessary Central Drugs Standard Control Organization (CDSCO) Approvals and Licenses for several stem cell-related products.
We have an excellent record of this collaboration, and we look forward to continuing this relationship in the times ahead.
Dr. Sayan Basu
This is to certify that we used the Regulatory Affairs Services of Nextvel Consulting LLP in the year 2020.
Nextvel led by Ms. Mala Srivastava, Co-founder & Managing Partner, supported us in obtaining the necessary Central Drugs Standard Control Organization (CDSCO) Approvals and Licenses for the product CRISPR-based IVD for SARS-COVID -19 Diagnostic Kit, in record time for timely launch of the product
We had an excellent experience working with Nextvel for obtaining approval for this product.
Girish Krishnamurthy
The extraordinary team of #nextvel consultants led by Mala Srivastava MRQA, led the entire process of the regulatory submission.