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DRUG DEVELOPMENT STRATEGY

Regulatory Affairs

Linical's Regulatory Affairs team provides expertise and resources to help early stage clients bring products into clinical development. We support biologics, drugs, and medical devices with a comprehensive understanding of both regulatory and clinical affairs – blended knowledge that provides sound guidance for our clients. These individuals have over 20 years of experience coordinating pre-IND packages, INDs, IDEs, 510Ks, BLAs/NDAs/PMAs/MAAs, regulatory submission strategies, regulatory meeting preparation and attendance, and clinical trial launches. We have successfully supported US, EU, and Asia Sponsors in their global regulatory filings.

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Linical’s regulatory expertise spans the globe, providing valuable guidance on diverse regulatory requirements and strategies for the most efficient pathway for your product.

Global Regulatory Affairs Capabilities

The global regulatory landscape is constantly evolving, with regulators strengthening their requirements in terms of safety and efficacy and implementing accelerated programs for submission to facilitate drug review and approval in areas of unmet medical needs or in emergency situations. In addition, the emergence of electronic solutions for document submission and review (such as CTIS in Europe) is streamlining approval processes, but can imply additional challenges, especially for small or mid-sized pharma and biotech companies.

At Linical, we have the expertise and know-how to face this challenging scenario, designing tailor-made strategies to optimize time and costs while complying with all regulatory requirements. We support biologics, drugs, and medical devices with a comprehensive understanding of both regulatory and clinical affairs – blended knowledge that provides sound guidance for our clients. Our team has over 20 years of experience coordinating pre-IND packages, INDs, IDEs, 510Ks, BLAs/NDAs/PMAs/MAAs, regulatory submission strategies, regulatory meeting preparation and attendance, and clinical trial launches. 

Through partnering with Linical, clients can:

  • Streamline the development pathway
  • Avoid unnecessary studies
  • Save money
  • Shorten timelines to get products to market
  • Gain valuable feedback from agency meetings to reach key inflection points and raise funds

Process

Regulatory Affairs for Clinical Trials

Operating in more than 40 countries, Linical has extensive experience in submissions to regulatory agencies in the main markets for clinical trials (FDA, EMA, PMDA, NMPA), having successfully supported clients across the Americas, Europe, and Asia in their regulatory filings. Our team considers the global perspective to identify key issues and setting goals, but designs plans aligned with the specifics of each region providing valuable guidance on diverse regulatory requirements and strategies for the most efficient pathway for your product.

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Regulatory Strategy Development Services
  • Expertise in regulatory strategy for drug development across the Americas, Europe and Asia Pacific
  • Expansion of regulatory services in Mexico and LATAM
  • Guidance and navigation through the changes from the previous Directive 2001/20/EC to Regulation (EU) 536/2014
  • Single e-submission for all countries via Clinical Trials Information System (CTIS)
Authoring of Regulatory Documents
  • CTAs/IMPDs, INDs, Maintenance Submissions
  • Marketing Authorization Applications
  • Fast Track and Orphan Drug Applications
  • Periodic Safety Update Reports 
  • Annual Reports, Protocol Amendments
Interactions with Health Authorities

Preparing Meeting Requests and Briefing Packages (Pre-IND, EOP1, EOP2, Scientific Advice from National Authorities, meetings with FDA, EMA, PMDA, NMPA, and other global regulators)

Post Approval Services
  • Review of promotional materials
  • Review of labeling changes
  • Strategic planning for new indications
GAP Analysis and Mitigation Strategies
Global Submission Project Management

Right Size
Right Reach
Right Team

Regulatory Support Services

Our regulatory support services are based on a clear understanding of the clinical trial objectives and their relationship to regulatory requirements leading to the development of ad-hoc solutions with well-defined priorities and detailed timelines, always with transparency and fluid collaboration with regulatory authorities.

We combine in-depth knowledge of local and international regulations with a proactive approach to risk management to help you navigate the regulatory process efficiently and effectively, avoiding unnecessary delays and improving the chances of successful approval. Learn more about Linical’s regulatory strategy and consulting solutions.

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OUR BENEFITS

Why Linical?

The clinical development journey can be daunting and often leads to failure. With so much riding on your compound, you deserve the best chance at achieving your goals and positively impacting patients across the globe.

As a global, award-winning CRO, we can provide the strategy and support you need to position your clinical trial for success. We have an impressive track record of exceeding our enrollment goals and maintaining nearly a 90% client retention rate.

With our collaborative approach and commitment to quality, Linical expertly guides you through each step of the process, from early-phase research to large-scale global studies. With Linical, you can overcome obstacles, expedite timelines, save valuable money, and achieve your goals without compromising quality.

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Successful clinical trials start with Linical.

Don’t let the complex clinical development journey hold you back. With Linical, you can overcome obstacles, save valuable time and money, and reach your goals. 

01 Request a proposal

We start by listening to your needs and understanding your goals to ensure we’re the right CRO for you.

02 Get a plan for success

We propose solutions that proactively tackle obstacles, optimize your trial design, and position you for success every step of the way.

03 Execute with confidence

We’ll guide you through each phase of the process, offering personalized support and a full range of services to help you achieve a successful trial. We are not a “one size fits all” CRO.

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