Navigating Global Health Authority Clinical Trials and Marketing Approvals
Your Regulatory Biotech Experts
Navigating Global Health Authority Clinical Trials and Marketing Approvals
Our Mission
At Innovative Regulatory Inc., our mission is to empower biopharma companies through providing unparalleled regulatory scientific and strategic approaches. Our regulatory affairs consulting services help our clients navigate the complexities of regulatory pathways and translate scientific data into successful drug product approvals to enhance patient access to life-saving medicines.
Biopharmaceutical Regulatory Consulting Services
R&D Product Development Strategy
We review overall development programs and assess gaps, regulatory risks and mitigations, as well as identifying opportunities to streamline the various milestone activities that are required to successfully execute a product development program.
Special and Expedited Regulatory Pathways
We identify the opportunities to leverage a variety of regulatory pathways for client product development programs and guide their successful execution. We can develop regulatory submissions and strategy to support:
- Orphan Drug applications
- Pediatrics: PSPs, PIPs, waivers, deferrals
- FDA: Animal Rule, Priority Review, Breakthrough Therapy, Fast Track, Accelerated Approval, EUA
- Health Canada: EUNDS, ACCESS Consortium
- EMA: PRIME, Conditional Approval
- Rx-OTC switch
- WHO EUL/PQ
Health Authority meetings
We prepare meeting requests, briefing books, slides and meeting scripts as needed. Post meeting, we de-brief with the team to help interpret the health authority feedback and identify any adjustments required to development program. We can support all meeting types including:
- FDA: Type A, B, C, D ( e.g. pre-BLA, EOPh2, INTERACT, pre-IND), Advisory Committee
- Health Canada: pre-CTA, pre-NDS/EUNDS
- EMA: Scientific Advice, pre-MAA, Oral Explanation
CTA, IMPD, IND Submission development and maintenance
We work with our clients to define the data and source documents required for CTA, IMPD, and IND submissions and compile, edit and review the required regulatory dossiers for successful clinical trial start-up. We help the team to address any Health Authority questions that may arise during the review process.
Marketing Authorization Applications
We can develop content maps, project plans, gap assessments, and write and review submission content for a variety of marketing authorization types, including Health Canada NDS and EUNDS applications, FDA BLA and NDA, and EMA MAA. We assist our clients throughout the license review process, helping to compile responses to Health Authority questions, updating dossier content, and assisting with product label negotiations.
Interim Regulatory Leadership
Innovative Regulatory Inc. provides interim regulatory team leadership solutions tailored for biotech companies. We can help guide our clients through critical phases, ensuring compliance and maintaining momentum in development programs, as well as the day-to-day management of client Regulatory teams. Having extensive experience in overseeing multifunctional regulatory teams, we can offer insights to optimize regulatory processes, regulatory team structure and scaling/re-organizing the regulatory affairs function.
Competitive Label Development and Labeling Operations
We provide strategic input into label claim development, giving consideration to clinical trial endpoint design to ensure that datasets are generated to support desired commercial product labeling. CCDS and labeling operational processes are key to creating and maintaining compliant labels and we are experienced in building sustainable systems, ensuring that labeling processes connect seamlessly with cross-functional systems ( i.e Pharmacovigilance, Manufacturing Ops, Quality)
Post-licensure Maintenance
We are experienced in all post-marketing submission types for Health Canada, FDA, EMA and globally, including CMC, Clinical, Device , Pharmacovigliance and Labeling updates. Additionally, we have extensive experience in leveraging the PACMP (post-approval change management protocol) pathway with FDA for CMC changes.
Audit Preparation
We assist our clients in helping to prepare for GMP, GCP and GVP audits, ensuring that story boards and required source documents are inspection ready, as well as technical SME regulatory support to help address questions during the inspection.
Source Document Preparation
We assist our clients in preparing and reviewing a variety of pivotal submission source documents such as product specifications, CMC reports (comparability, stability, process, validation, analytical), Investigator Brochures , Clinical Study Reports, and Pharmacovigilance RMPs.
Innovative Regulatory Advantages
Expert Regulatory consulting across therapeutic modalities and global jurisdictions
We offer extensive regulatory technical experience in clinical trials and marketing applications for vaccines, anti-toxins, small molecules, therapeutics, monoclonal/bi-specific antibodies, plasma-derived products, synthetic protein therapies, devices (pre-filled syringe, nasal spray, auto-injector) and combination products, covering US, Canada, EU, and other global markets.
Flexible Tailored Solutions
Understanding that each project and team is unique, Innovative Regulatory Inc. offers expert regulatory consulting to biotech firms navigating the regulatory maze. Our focus is on delivering timely and effective solutions tailored to be flexible to your needs from a technical, strategic and leadership perspective. We work closely with clients to develop strategies that align with their objectives.
Special and Expedited Regulatory Pathways
Navigating regulatory pathways can be daunting. At Innovative Regulatory Inc., we have a proven track record of success in all expedited and special regulatory pathways, including Fast Track, Breakthrough Therapy, Priority Review, Accelerated Approval, Animal Rule, Orphan Drug, EUNDS, and Conditional Approval. At Innovative Regulatory Inc., we leverage our experience to maximize client project success.
Our Values
Curious by nature
What sets our regulatory affairs consulting services apart is our desire to be open to possibility and learning. We drive dialogue that sparks new ways of thinking, creates mindset shifts and enables the exploration of new opportunities. We ask the questions: What hasn't been tried yet? What is a different way of seeing this? The scientific discoveries of our clients deserve the kind of curiosity that transforms ideas into life-saving medicines.
Agile by design
Our pharmaceutical regulatory affairs consultancy offers the flexibility and collaboration our clients need, all whilst providing best-in-class biopharma regulatory consulting. Our breadth of experience enables us to develop regulatory strategies and execute on solutions that drive value no matter the development stage, size of company, or complexity of program. We know what it takes to cross the finish line to drug approval and are agile in how we get there.
Regulatory Excellence always
Regulatory Excellence always
Regulatory excellence is in our DNA. Whether its preparing for a pivotal Health Authority meeting or the more day-to-day activity of reviewing of a submission source document, we apply the same high quality standards and urgency to our work to ensure maximum value to our clients. We are regulatory biotech experts and we provide exceptional execution to fulfil our client commitments.