Montefiore Life Sciences provides strategic, regulatory, and analytical services to pharmaceutical, biopharmaceutical, nutraceutical, and cosmetic companies. We specialize in in vitro testing methodologies (IVRT/IVPT), regulatory submissions, and compliance strategy — delivering precision where it matters most.

Specialized Expertise: In Vitro Bioequivalence Support

We offer comprehensive support for sponsors submitting Abbreviated New Drug Applications (ANDAs) or managing post-approval regulatory activities related to topical and transdermal products. Our expertise is grounded in successful engagements with FDA, EMA, and Health Canada, and reflects the latest expectations under GDUFA III and global regulatory frameworks..

1. Study Protocol Development & Review

Custom design and optimization of IVRT/IVPT protocols for bioequivalence, aligned with product-specific guidance and submission requirements.

2. Regulatory Interaction & Response Strategy

Strategic preparation of CRL responses, RfRs, and post-CRL clarifications (CRCMRS), including support for FDA meetings and correspondence.

3. Controlled Correspondence & PSG Engagement

Drafting and submission of Controlled Correspondence; strategic use of Product-Specific Guidances (PSGs), public comments, and GDUFA tools.

4. Facility Readiness & Submission Preparation

Internal audits, facility data alignment (Modules 1–3), and inspection preparedness to mitigate filing risks.

5. eCTD & FDA Form 356h Compliance

Electronic submission support, technical validation, and lifecycle document management.

6. Post-Submission Regulatory Strategy

Support for clarification letters, post-submission meetings, and BE methodology alignment for supplements and change control.

Core Capabilities

We offer a full spectrum of regulatory, quality, and commercialization services across five integrated service domains:

    • End-to-end support for submissions, approvals, and lifecycle management

    • Import/export licensing and global market authorization

    • Regulatory strategy development and CTD/eCTD dossier preparation

    • Facility qualification and validation per cGMP, GLP, and ISO standards

    • Internal audits and support for regulatory inspections

    • QMS implementation, SOP drafting, and compliance best practices

    • Analytical method development, validation, and transfer

    • IVRT and IVPT studies for topical and transdermal formulations

    • Stability testing and QC studies for product release and submission

    • On-site and virtual training on GMP, GLP, and regulatory topics

    • Technical workshops tailored to development and compliance teams

    • Scientific advisory on formulation strategy and lifecycle risk management

    • Regulatory-compliant branding, packaging, and product labeling

    • Market access strategy and commercial launch support

    • Distribution network development across regulated and OTC markets