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our
services

When you need been there, done that

regulatory expertise embedded in your team

Interim Heads of Regulatory
Global Regulatory Strategists
Submission Readiness and Management
US Agent & FDA Authorized Contact

Interim Heads of Regulatory

Our interim leaders, all experienced former heads of regulatory affairs, are ready to step in and seamlessly take the helm of your regulatory function.  Whether planned or unexpected, the departure of your Vice President of Regulatory or Chief Regulatory Officer can spell uncertainty and potential disruption for your company's development plans and relationship with regulators.  Minimize the impact by quickly inserting an experienced regulatory leader to ensure seamless execution of regulatory plans and strategies, maintain a senior regulatory voice, and support your regulatory team to ensure retention.

We also support emerging companies heading into the clinic but not yet ready for a fulltime head of regulatory.

Global Regulatory Strategists

All of our regulatory strategists are highly-experienced global regulatory leads are adept at quickly embedding into your organization and prepared to independently assume leadership of your program's regulatory strategy, activities, and regulator relationships.  Our consultants assume the role at any stage of development and can deliver regulatory clarity by assessing the regulatory landscape and developing a solid global regulatory strategy.  As the regulatory lead on your program team, they drive submission preparation, including INDs and marketing applications, lead health authority interactions, and evaluate special designations and other regulatory vehicles to accelerate the development and approval of your products.

Submission Readiness and Management

At no other time in your company’s development have strategic clarity, operational excellence, and strong leadership been more needed and more rewarded than your first IND or marketing application.  Submitting a complete and high-quality application as soon as possible has enormous benefits for your company and your patients.  Give your team the support and guidance of consultants who have unrivalled expertise leading IND, BLA, and NDA teams to success.  We integrate into your team and leverage your in-house talent, building institutional knowledge.  We use a proven approach for planning and preparing applications to turn a formidable task into a confident drive to success. Our team of seasoned regulatory project managers and regulatory strategists have extensive experience managing all types of submissions, including INDs, CTAs, NDAs, BLAs, and MAAs and related health authority meetings.  Collaborating closely with your regulatory leads and program team members, our versatile and collaborative consultants will guide your team towards high-quality and timely submissions.​

Due Diligence

Our firm provides expert regulatory affairs due diligence services to assess the regulatory clarity of the program to support pharmaceutical licensing deals. We evaluate the product’s regulatory history and market-specific approval pathways. Our team identifies potential risks, gaps in development to support entry into the clinic or registration, ensuring a clear understanding of the product’s regulatory standing.

By delivering actionable insights, we help licensors and licensees mitigate risks, navigate complex regulations, and negotiate with confidence. With our thorough assessments, clients can make informed decisions, facilitating smooth transactions and successful partnerships.

US Agent & FDA Authorized Contact

Serving as US Agent or your Authorized Contact with FDA, our team of experienced professionals simplifies the regulatory journey into the US regulatory environment and ensures seamless communication with FDA, mitigating risks and enabling your business to focus on innovation and growth. We act as the official communication channel between your company and the FDA, ensuring timely and accurate exchanges of critical regulatory information, including responding promptly to FDA inquiries and responses, inspection notices, compliance correspondence, and emergency notifications.

U.S. Agent for Foreign Companies

For pharmaceutical companies outside the United States, we act as the FDA-mandated U.S. Agent to provide:

  • Official Representation: Serve as the primary liaison between your company and the FDA, ensuring all communications, including compliance inquiries, are handled promptly and professionally.

  • Emergency Notifications: Receive and respond to FDA notifications, such as product recalls or inspection alerts, ensuring immediate action and regulatory compliance.

 

FDA Authorized Contact for U.S. Companies

For U.S.-based pharmaceutical firms, we offer expert representation and act as your FDA Authorized Contact to provide:

  • Direct Communication with the FDA: Ensure accurate, efficient, and professional communication with the FDA during product development, market approval, and post-market stages.

  • Cost-effective Solution: Ideal for companies with small or virtual regulatory teams.

Regulatory Advisory Board

Access our senior management and a high-level and seasoned network of experts to review and provide opinions and guidance on your most challenging development questions and plans. Benefit from the insight of the most experienced fit-for-purpose colleagues in our industry on an ad hoc basis as needed to assess gaps, advise, and build confidence in your strategy.

Due Diligence
Regulatory Advisory Board

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