Services We Offer
FDA / EMA Regulatory Application Submission Services & Clinical Trial Design
Services to help get you on a path to improved FDA and/or EMA regulatory compliance. We will work with you through every step of your product's regulatory approval process.
Experienced Startup Advising and Consulting
We offer various short and long-term options to help you succeed. We provide guidance, coaching, review and feedback of pitchdecks for investor and partnership meetings.
Branding, Website Development & Digital Marketing Services
We'll help attract the customers and credibility you deserve! Service packages vary with all inclusive logo design, branding, website development, digital advertising, social media marketing, or partial service options for a flat rate. We also offer individual service options. Need help converting leads to paying customers? We have experts to help with that too! We won't surprise you with hidden fees!
Business Planning, Development, Project Management & Globalization Strategy Services
We offer startup business planning, R&D guidance, business development, project management and globalization strategy services to help bring your product or device to market. We will aid in finding and negotiating suitable partnerships and investor opportunies.
Value Proposition
Boston Biotech Advisors stands as the apex of biotechnology regulatory and startup consulting expertise. With an elite team of specialists spanning biotech, regenerative medicine, business development, regulatory affairs, clinical trials, and finance we wield unmatched expertise. We empower founders with research backgrounds, equipping them with essential business acumen to assert control over their ventures and thrive as entrepreneurs, ensuring their sustainable growth and success. Our firm is distinct in relentless pursuit of innovation, with disruptive methodologies like remote incubator-like programs and state-of-the-art online self-help platforms challenging the status quo. Our flexible tools allow clients to take control of their busy schedule and gain essential support through their fast-paced work environment. By combining AI and industry expertise, we accelerate and streamline all operations. Clients gain access to valuable insights, best practices, and actionable strategies at their own pace and convenience, saving time and costs. Additionally, our specialized marketing and branding services help biotech entities to stand out and dominate among competitors.
Regulatory Application Submission Services
We have international experience with both the Food and Drug Administration (FDA) and European Medicines Agency (EMA)
Regulatory Strategy Development
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Tailored regulatory roadmap creation specific to your drug's therapeutic area and target indication.
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Identification of the optimal regulatory pathway and submission strategy (e.g., expedited programs like Fast Track, Breakthrough Therapy).
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Risk assessment and mitigation strategies to address potential hurdles.
Pre- Regulatory Body Meeting Preparation
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Comprehensive preparation of pre-regulatory body meeting briefing documents.
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Coordination and facilitation of pre-meetings with FDA, including scheduling and logistics.
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Representation during FDA meetings and follow-up actions based on FDA feedback.
CMC (Chemistry, Manufacturing, and Controls) Documentation
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Development and compilation of the CMC section, including detailed information on drug substance and drug product manufacturing processes.
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Guidance on the selection of appropriate manufacturing facilities and ensuring compliance with cGMP regulations.
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Preparation of stability studies, analytical methods validation, and quality control procedures.
Nonclinical Study Design & Documentation
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Design and oversight of nonclinical (preclinical) study programs, including toxicology, pharmacokinetics, and pharmacodynamics studies.
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Data analysis and interpretation to support the safety profile of the investigational drug / product / device.
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Preparation and submission of the nonclinical study reports per FDA guidelines.
Clinical Development Plan
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Development of the clinical trial design, including selection of endpoints, patient population, and study phases.
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Preparation of clinical protocols, investigator brochures, and informed consent forms.
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Coordination with CROs (Contract research Organizations) for Clinical trial execution.
Electronic Common Technical Document (eCTD) Submission
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Formatting and organization of the application in eCTD format for electronic submission.
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Quality control checks to ensure compliance with regulatory submission guidelines
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Management of the entire submission process including electronic submission through the FDA's ESG (Electronic Submissions Gateway).
Regulatory Writing & Documentation
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Preparation of all required sections of the application, including the summary, general investigational plan, investigator information, pharmacology and toxicology information, etc.
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Complilation of supporting documentation such as SOPs, certifications, and prior study reports.
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Ensuring all documents are accurate, consistent, and meet FDA / EMA regulatory requirements.
FDA Communication & Liaison Services
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Acting as the primary point of contact between client and the FDA / EMA throughout the application submission and approval process.
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Handling all correspondance, responses to the FDA/EMA queries, and provision of additional information as requested.
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Ongoing regulatory support post-submission, including amendments, annual reports, and updates as necessary.
Project Management & Coordination
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End-to-end project management to ensure timely submission of the application.
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Coordination between internal teams, external consultants, and third-party vendors.
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Regular updates and communication with the client regarding project milestones and progress.
Risk Management & Compliance Monitoring
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Continuous monitoring of regulatory compliance throughout the application process.
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Identification and management of risks related to regulatory submissions.
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Implementation of corrective actions to address any compliance issues that may arise