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Clinical Trial Regulatory Services

Outsource Clinical Trial Regulatory Services

Outsource clinical trial regulatory services to support and strengthen your drug discovery trials and tap into therapeutic expertise with complete confidence starting at $1280/month per FTE

Clinical research is the heart of every drug discovery. Not only does it help pharmaceutical companies to assess the efficiency and efficacy of drugs, but it also enables health authorities to ascertain the risk benefits and the safety of the new drug under development. However, seeking approval for clinical trials is a lengthy and complicated process that requires complete professional expertise. For approval, the pharmaceutical companies have to submit multiple regulatory documents as part of the dossier submission, along with meeting the current good clinical practice regulations - a process that consumes a lot of their time.

Outsource2india (O2I) is a full-service clinical trial regulatory service providing company that offers comprehensive assistance for clinical trial data and dossier compilation and submission. Our competent team of clinical and regulatory experts helps pharmaceutical companies, drug manufacturers, and clinical research organizations (CROs) chalk out the most effective and efficient regulatory pathway for seeking regulatory approvals. They compile and manage all aspects of clinical development programs and provide proficient regulatory strategic consulting and gap analysis services to help CROs seek necessary clinical trial approvals from various health authorities.

Clinical Trial Regulatory Services Offered by Outsource2india

Outsource2india is a leading clinical trial regulatory company that's dedicated to helping drug manufacturers and pharmaceutical companies effectively meet the regulatory and auditory compliance required during the clinical trial approval process. Our regulatory experts have in-depth knowledge of all the regulatory procedures laid by different global regulatory agencies and can help pharmaceutical companies, big and small, prepare, compile, and submit a robust clinical trial application dossier for necessary permissions and approvals. Experts at O2I can help you coordinate and manage all aspects of your clinical development program and overcome all possible technical challenges that may otherwise derail or slow down your drug development process.

Our services include -

  • Regulatory Writing Services

    Regulatory Writing Services

    We can assist you in designing and customizing clinical research protocols for all types of formulations across all stages of drug development. We can help you write, edit, and organize a range of high-quality clinical trial regulatory and safety documents that are required for safely carrying out clinical trials in India and abroad. You can use our services to create development plans for process validation, study protocols, stability study reports, pre-clinical and clinical study reports, technical documents, safety narratives, and more.

  • Dossier Compilation

    Dossier Compilation

    Our regulatory experts can help you compile and organize all types of clinical trial documents as per the requirements of Asean Common Technical Dossier (ACTD) Guidelines, Common Technical Dossier (CTD) Guidelines, Drug Master File (DMF), and more.

    We have vast experience in creating and compiling critical regulatory documents and applications, including those about Investigational New Drugs, Investigational Medicinal Product Dossier [IMPDs], Clinical Trial Applications [CTAs], New Drug Applications [NDAs], New Drug Submissions [NDSs], Abbreviated New Drug Applications [ANDAs], Biological License Applications [BLAs], and Market Authorization Applications [MAAs]).

  • CTA Submission and Maintenance

    CTA Submission and Maintenance

    We also provide comprehensive assistance for the submission of CTA to the regulatory authorities. From creating country-specific CTAs to managing the regulatory aspects to maintaining the timelines and determining submissions, we do it all to make your application process smooth and hassle-free.

  • Regulatory Consultancy

    Regulatory Consultancy

    We offer complete advice and consultancy services for all types of regulatory affairs. Our consultancy services help pharmaceutical companies ease down the regulatory burden of different stages of drug development, including the planning and development of CMC documents, investigator's brochure (IB), and Investigational Medicinal Product Dossier.

Clinical Trial Regulatory Process We Follow

At O2I, we strive to be your partner in your clinical development journey. Our processes and solutions have been expertly designed to bring disintegrated processes together, allowing you simultaneously manage multiple regulatory submissions, right from the start to finish.

Our process includes -


01. Assessing Your Requirements

We meet you to assess and understand your clinical trial management requirements and analyze the scope of work required


02. Creating a Clinical Trial Regulatory Framework

We then get down to create a comprehensive clinical trial application dossier that expertly meets all the key clinical research regulations and requirements. While doing so, we review all the clinical data generated during the research, developmental, and execution stages to ensure nothing gets missed while applying


03. Dossier Submission

Once created and complied with, we help you submit your clinical trial dossier to the corresponding health authorities for necessary approvals. We make sure to adhere to their timelines and requirements for full approvals


04. Liaising and Negotiating with Regulatory Authorities

We also coordinate with regulatory authorities for complete case support and management

Benefits of Outsourcing Clinical Trial Regulatory Services

Outsourcing clinical trial regulatory services to experts can help you -

  • Ensure timely and expert-reviewed submission and maintenance of regulatory applications.
  • Gain expert advice on all regulatory matters.
  • Create dossiers as per different health authorities' rules and regulations.
  • Enjoy comprehensive regulatory services without extensively increasing your overhead costs.
  • Get complete document creation, management, and compilation support as per different regulatory bodies.
  • Save your precious time and money.

Other Services You Can Benefit From

Why Outsource Clinical Trial Regulatory Services to Outsource2india?

Outsource2india is a premium clinical trial regulatory service providing company offering integrated, end-to-end clinical research solutions in India and abroad. Backed by a dexterous team of clinical trial experts, we work with a mission to be the finest and single-point research destination for global pharmaceutical and biotech companies. With a two-decade-long experience in the industry and having worked with various regulatory agencies worldwide, we offer a wide range of high-quality, result-oriented clinical research regulatory writing and project management services for drug discovery trials, bioequivalence studies, PK / PD studies, medical writing, and pharmacovigilance services.

Outsource clinical trial regulatory services to us and enjoy -

  • Customized Services and Solutions

    We offer customized clinical regulatory services to seamlessly integrate our solutions with your drug development requirements. Our tailored solutions also allow you to meet the regulatory protocols of various regulatory agencies across the globe.

  • Cost-effective Pricing

    We offer our regulatory writing and dossier compilation services at extremely cost-effective rates. This allows us to serve all drug development companies, big or small.

  • Instant Access to Certified Experts

    Our certified CRO experts help us to chalk out the most effective regulatory pathways and provide expert clinical trial regulatory services in India and abroad. With years of experience in regulatory services, they make the entire process quick, seamless, and effective.

  • Quick Turnaround Time

    Our efficient teams and global delivery centers help us to quickly and effectively meet our client's varied requirements and provide our services in the most time-efficient manner.

  • Complete Data Privacy

    We understand how vulnerable clinical research data is. That's why we ensure the complete safety and privacy of your clinical research data. Under no circumstances is your information shared with anyone without your prior consent.

  • Single Point of Contact

    Our dedicated project managers act as your single point of contact. With the complete information about your project cycle, they keep you abreast with all the project developments and requirements.

  • 24/7 Service Support

    Our customer service executives are available 24/7, 365 days a year, and assure instant support and timely resolution of all your queries and concerns.

  • Complete Peace of Mind

    With us, you no longer have to worry about your clinical regulatory service requirements. Leveraging our stringent processes and expert process knowledge, we smoothen out your drug research journey - right from plan creation to obtaining regulatory approvals, allowing you to rest easy knowing your assets are being managed by experts.

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Hello, I wanted to reach out to you directly and express my gratitude for the hard work that the Data team, as well as the AR team, has done with EJ practice. I have pushed both teams extremely hard over the past month and their efforts, as well as ours, have paid off.

RCM Account Manager, EMR System Provider, FL, USA More Testimonials »

Outsource Clinical Trial Regulatory Services to O2I

As a leading clinical trial regulatory service provider, O2I offers full-service clinical trial management solutions to pharmaceutical companies, big and small. Our expert healthcare solutions and centralized data management repository facilitate the seamless documentation and submission of your regulatory dossiers, no matter where in the world you operate. We allow you to simultaneously manage multiple regulatory submissions with a 100% success rate. Whether you need help in designing the clinical trial protocols or are looking for expert support for complicated regulatory submissions, we can be your partner in success.

Get in touch with us to know more about our clinical trial regulatory services or to seek our expert advice. We are just a call away!

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