Regulatory Consulting

The Linical team has deep knowledge of global drug development, and we provide clients world-class regulatory consulting services. Our approach is tailored to each unique program, and our strategies help clients successfully navigate the regulatory process in the most cost effective and quickest to market manner.

Regulatory Strategy and Consulting Services

An in-depth understanding of the global regulatory environment is critical to successfully navigate through its complexities and constant changes. Linical provides advice and guidance to pharmaceutical and biotech companies in the design and implementation of regulatory strategies, ensuring compliance with the requirements and regulations set forth by regulatory agencies.

We provide regulatory consulting services at all stages of drug development including study design, regulatory compliance, protocol development and patient recruitment with the goal of helping sponsors minimize risks and optimize their decision-making processes.

With presence in all major clinical trial destinations, Linical provides global and regional support, with a special focus on the Asia Pacific (APAC) region, given our Asian footprint. We have local experts with years of experience and relationships with regulatory agencies capable of guiding sponsors through the regional regulatory nuances to ensure the success of their product development plans.


Interested in the Japanese Market?

Linical supports venture biotech and pharmaceutical companies interested in entering the Japanese market but unfamiliar with its regulations. We also support organizations seeking strategic partners to distribute and commercialize their products in Japan. Our team of local experts have years of experience in clinical development, medical writing, regulatory affairs, project management, licensing, and business development in the pharmaceutical and CRO industry. This allows us to provide comprehensive support to biotech and pharma companies from the earliest phase of development. Linical is your gateway to the Japanese market.

Our Japanese market regulatory consulting services include:


Market Analysis & Research
  • Patient forecast
  • Market value and forecast.
  • Treatment algorithm and guidelines
  • Approved products and major pipelines
  • Target product profile
Development & Regulatory Strategy, PMDA Consultation, Medical Writing
  • Proposal for clinical development and regulatory strategy
  • Application and preparation of materials for PMDA consultation meeting
  • Presence at PMDA meeting with or without the client
  • Writing the Investigator Brochure (IB), protocol and Informed Consent Form (ICF)
  •  Submission of Clinical Trial Notification
  • In-Country Clinical Caretaker (ICCC)
  • Orphan designation registration
Strategic Partnering/ Licensing
  • Search and analysis of potential partners.
  • Approach to potential partners and introduction of the client’s product
  • Arranging meetings and mediating communication between the client and potential partners
  • Attendance to partnering conferences with or without the client
  • Due diligence support

Regulatory Support Across the Globe

Wherever in the world your clinical development needs take you, Linical has regulatory experts in that region to successfully guide you. Learn more about our locations.

Right Size
Right Reach
Right Team

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.

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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