Regulatory Guidance for Complex Manufacturing Programs
From early-stage formulation to GMP manufacturing, Parimer provides regulatory support that keeps programs compliant and moving forward.
Support Through Every Regulatory Stage
We help clients navigate complex regulatory requirements. Our team integrates scientific expertise with regulatory insight to ensure every process, from R&D to commercial scale, is documented, validated, and compliant. Whether preparing for pre-IND meetings or managing post-approval changes, we provide tailored guidance that aligns science with regulation.
Our Regulatory Collaboration Process
Every project begins with understanding program goals, development history, and compliance challenges. We then provide a phased plan to achieve regulatory readiness.
Assessment
Review of current documentation and processes
Gap Analysis
Identify regulatory and validation needs
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Implementation
Execute and document updates
Submission Support
Authoring and review of regulatory materials
Regulatory Guidance Services
Regulatory Strategy Development
Roadmapping submissions, documentation, and testing aligned with FDA and ICH guidelines.
CMC Documentation Support
Authoring and reviewing CMC sections for INDs, NDAs, and DMFs.
Process Validation Support
Guidance through IQ/OQ/PQ, cleaning validation, and analytical method validation.
Regulatory Audits & Readiness
Preparation for FDA, EMA, and ISO inspections.
Post-Approval Support
Managing regulatory updates and lifecycle submissions.
Science-Driven, Regulation-Ready
Parimer combines deep technical expertise in polymer science and pharmaceutical manufacturing with an understanding of the evolving regulatory landscape. Our clients rely on us for strategies that are not only compliant but scientifically sound and efficient.