Regulatory Consulting Services

Trusted regulatory consultants to help navigate complexity

As your programs approach pivotal milestones, clear expectations and strategy matter more than ever. Our regulatory consulting services help ensure progress by aligning approach, planning, and execution.

We partner closely with your team to reduce uncertainty, protect timelines, and support confident decision-making.

Our regulatory consulting services include:

Regulatory pathway assessment and strategic planning: Identify the most efficient approval pathway with designations and expedited programs based on product type, indication, and development stage, then establish a strategy to minimize risk and rework.
Support for pivotal regulatory milestones and FDA/EMA submissions: Prepare, review, and submit regulatory documentation, plus ongoing support for lifecycle maintenance, and engagement with agencies.
International experience and regulatory engagement: Enhance communication and interactions with the agencies to maintain momentum and clarity for both domestic and internationally based programs.
Integrated GXP compliance consulting and remediation: Ensure quality compliance across clinical, laboratory, and commercial operational stages for both internal and partner organizations.
Workplace and downstream material safety services: Manage hazard communication and product stewardship requirements with responsive, scalable solutions.

Explore our Regulatory Resource Library

Discover more about the regulatory pathways, filing guidance, and compliance expertise offered by a range of our consultants.

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Regulatory affairs consulting, built around your program

Our regulatory affairs consultants provide unique expertise to advance treatments for disease communities with a high unmet medical need. We help with the identification of optimal pathways, preparation of documents, and providing ongoing oversight to maintain progress.

Regulatory Strategy and Advisory Support

Our regulatory consultants offer deep experience across pharmaceuticals, biologics, gene therapies, and drug–device combination products. We help shape clear regulatory strategies grounded in U.S. and EU requirements, aligned to your science and development realities, including:

Regulatory strategy and advisory consulting
Gap analysis and feasibility assessments
CMC consulting to support data collection and submissions

Designations and Expedited Pathways

Partnering with our experienced teams helps provide strategic regulatory guidance and filing preparation. By identifying alternative product categories that may be relevant to the product or patient populations, we help evaluate and pursue pathways by preparing submission materials for various designations, including:

Orphan Drug Designation and annual reporting (FDA and EMA)
Rare Pediatric Disease Designation
Regenerative Medicine Advanced Therapy (RMAT) Designation
Qualified Infectious Disease Product (QIDP) Designation
Expedited programs, including Fast Track Designation and Breakthrough Therapy Designation

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Regulatory Agency Interactions

We prepare you for meaningful, productive engagement with regulatory agencies, from early planning through live meetings. Our team supports strategy development, content creation, and real-time participation with:

FDA meeting types A, B, C, and D
INTERACT, Pre-IND, End of Phase 1/2 (EOP1/2), Pre-NDA, and Pre-BLA meetings
EMA Scientific Advice meeting

IND Application Authoring

Our experts provide end-to-end support for regulatory applications, combining strong scientific writing with in-house publishing capabilities to ensure submissions are accurate, consistent, and ready.

Authoring and review of regulatory documents
IND, NDA, BLA, and 505(b)(2) NDA applications
Content development, QC, and formatting review

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eCTD Publishing and Submission Support

We manage the technical complexity of electronic submissions so your team can focus on the science. Our support spans preparation through submission and lifecycle management, including:

Initial IND submissions
Annual reports and Development Safety Update Reports (DSUR)
Meeting requests and briefing packages
CMC and protocol amendments
Safety reporting
US Agent service

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Regulatory compliance consulting tailored to your programs and partners

Gain expert quality assessments, guidance, and validation from development through commercialization for both internal and partner organizations.

Early- and clinical-phase support

Align compliance strategies with requirements relevant to each development phase, such as GLP, GCP, GCLP, and GMP guidance.

Commercial compliance

Leverage assessments, guidance, and facility services at your own locations and with partner organizations.

Audits and validation

Evaluate and maintain compliance with third-party and supplier audits, remediation guidance, and workshops and training. We also support master plans and scalable validation for equipment, systems, and processes.

Explore GxP services and auditing

Maintain compliant operations with facility qualifications

Satisfy stringent regulatory requirements when launching new or maintaining existing facilities with scalable support.

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Navigate hazard communication and product stewardship requirements

Hazard communication
Product stewardship

Hazard communication

Whether your needs range from strategic hazard communication programming to more tactical support, such as safety data sheet (SDS) authoring services, we customize our approach to address the specific challenges you face. Services include:

Large volume projects
Single SDS projects
Domestic and international SDS and label authoring
Product label reviews
Foreign language translations

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Product stewardship

With continuously increasing compliance requirements, we help you navigate product stewardship expectations using our chemistry expertise paired with a deep understanding of current global regulations. Our expertise includes:

California Proposition 65
EU REACH and ROHS
Toxic Substances Control Act (TSCA)
Product Label Reviews
Cleaning Product Right to Know Act (SB 258)

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Related services

Get in touch

Whether you’re shaping early plans or preparing to scale, our teams are here to help you move forward with clarity and confidence. Start the conversation and we’ll get back to you quickly.

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