The HIR Group provides biotechnology, pharmaceutical, diagnostic, and medical device organizations with specialized regulatory, scientific, and technical consulting throughout the product development lifecycle.
Our multidisciplinary team supports complex development programs by translating scientific, clinical, technical, and regulatory information into clear, compliant, submission-ready documentation. Our experience spans FDA, MDR, IVDR, pharmaceutical CMC, clinical and performance evaluation, quality documentation, regulatory remediation, and global submission support.
We work collaboratively with scientific, clinical, regulatory, quality, and technical subject matter experts to develop and align documentation across the product lifecycle—from early development and regulatory strategy through submission, approval, and post-market activities.
- Regulatory & Technical Writing: Development, review, and remediation of scientific, clinical, technical, CMC, and regulatory documentation supporting FDA and international regulatory pathways.
- Pharmaceutical & CMC Support: Technical authoring and development support for pharmaceutical CMC, manufacturing, formulation, analytical, quality, and related regulatory documentation.
- Medical Device & IVD Regulatory Support: MDR and IVDR documentation, clinical and performance evaluation, technical-file development and remediation, and post-market documentation.
- Scientific & Clinical Strategy: Evidence evaluation, literature review, clinical-development support, scientific communications, and translation of complex scientific information into regulatory strategy.
- Regulatory Lifecycle Support: Strategic support from early product development and regulatory planning through submissions, agency interactions, remediation, and post-market activities.
Tell us what you’re developing, where you are in the product lifecycle, and what challenges you’re facing. We’ll help identify the regulatory, clinical, scientific, or technical support that best fits your program.
Find the Right Support for Your Program
Not sure what support you need? Let us help you identify the right path.
Partner with The HIR Group to advance your product from scientific concept through regulatory development and commercialization.
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Tell us about your program, development stage, and regulatory or technical needs using the Request for Proposal form below. Our team will evaluate your requirements and discuss an engagement tailored to your development objectives.