International Regulatory Affairs

Managing, guiding and expediting regulatory approval initiatives in the US, Europe, Israel and growth regions – from concept to commercialization

With a regulatory track record that speaks for itself, Dor helps start-ups, incubators, established companies, researchers and VCs bring their products promptly to the market.

Get the edge for drugs, combination products, biologics, small molecules and biosimilars

Companies rely on Dor for end-to-end management and targeted regulatory expertise in the US, EU, and emerging markets for the entire product lifecycle – from pre-clinical development to human studies, from pilot to commercial manufacturing and from development to final authorization and post-commercialization maintenance.

Overcome regulatory obstacles with those who have done it before

Dor has extensive experience working with the FDA for US-wide product approvals, the EU for the range of submission procedures, including centralized, decentralized, mutual-recognition and national, and other agencies worldwide to achieve regulatory compliance.

Whether you are seeking first-time approval for a new drug or launching a global roll-out for an expanding local product, Dor knows how to navigate the regulatory landscape to achieve market authorization.

Complete life cycle support

With Dor, you can streamline the process to renew products under maintenance or to pursue approval for new indications, pharmaceutical forms or routes of administration.

The Dor team knows how and when to challenge limits and push the envelope – taking calculated risks based on career-long experience and knowledge.

Driven to stay ahead

Dor foresees and overcomes regulatory roadblocks with creative solutions – long after others have given up. As a pharmaceutical industry insider, Dor anticipates changes in regulations to prevent surprises and keep customers on track.

For highly promising drugs, Dor works to take advantage of the FDA’s Breakthrough and Europe’s PRIME fast-track programs, shortening time to market and quickening patient benefit.

Putting Dor to work for you

As Dor’s satisfied clients attest, Dor professionals are passionate about achieving customer goals, are committed to the mission and stand behind their advice.

A guiding hand during each mission-critical stage in the lifecycle

Dor’s services inspire success in the journey to regulatory approval:

Regulatory Strategy

  • Provide insights on international regulatory requirements throughout all product life cycle stages
  • Propose regulatory strategies on the best way to approach international regulatory agencies to speed time to market, including orphan, fast-track, and breakthrough therapies

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  • Create development road maps that cover plans, timelines, critical paths and cost projections
  • Advise on preclinical research. clinical phases I – III and chemistry, manufacturing and controls (CMC)
  • Manage/support quality/CMC, including CRO evaluation/selection based on standard requirements, as well as manufacturing design and ISO/GMP standards.
  • Prepare and submit packages for meetings with regulatory agencies for initial and advanced stages (IND/CTA, etc.)
  • Complete, review, publish, and maintain regulatory files throughout product development
  • Establish hearing and negotiation strategy, anticipate potential responses, proactively advise on questions that may arise and prepare briefing packages and presentations
  • Represent clients and negotiate in all interactions with regulatory agencies – both written and face to face
  • Supervise/audit clinical and manufacturing sites, both in-house and subcontracted, and evaluate protocols

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  • Author, review and publish complete regulatory dossiers or specific common technical documents
  • Enable eSubmission (eCTD) support with state-of-the-art tools
  • Prepare for reviews and meetings with regulatory agencies
  • Evaluate regulatory agency reviews, develop optimal responses, and conduct negotiations

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Dor Regulatory Assessment

  • Review and assess files, including protocol and common technical document (CTD) modules
  • Perform a gap analysis between prepared files and regulatory agency requirements
  • Conduct feasibility and due diligence assessments

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  • Maintain products and renewals
  • Expand product marketing authorization by submitting requests for variations, new indications, pharmaceutical forms or routes of administration
  • Manage change control and notifications
  • Submit periodic and annual reports

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Your Dor advantage

  • Accelerate regulatory approval and time to market
  • Obtain creative solutions to show-stopping obstacles
  • Get it right the first time; meet scheduled milestones and prevent rejections
  • Stay cost-efficient: Receive quality world-class services at reasonable rates
  • Gain access to the Office of the Israeli Chief Scientist for funding, support, networking, etc
  • Rely on the backbone of a full-service, big-picture consulting firm