our approach aimed at maximizing productivity & efficiency.
US FDA Consultants
US FDA Consultants aim to equip our clients with the information they need to comply with the FDA’s most recent requirements, allowing them to produce the highest quality pharmaceuticals, food, cosmetics and medical devices available.
As an FDA Consultants team, RegHelps SRC is made up of a powerful combination of compliance, regulatory, scientific, and technical experts who are very good at solving and documenting problems.
US FDA Consultants for Facility Design
When manufacturers face facility-related compliance challenges, our FDA Consultants is experienced in providing suitable world-class layout and design covering all regulatory obstacles.
Layout Design for Medical Device, Drugs and Nutraceutical Industries.
Site Approval – Area / Land / Site approval for the construction
US FDA Consultants for GMP Implementation
At RegHelps, we take pride in being the trusted FDA Consultants for GMP Implementation and FDA Audit readiness for health care manufacturers across the globe. Our experienced team has been instrumental in helping clients achieve Zero Non conformities (483,s)
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FDA Pre and Post Inspection support
We conduct realistic mock inspections to prepare manufacturers for actual FDA audits. Our team identifies potential gaps, evaluates documentation, and offers actionable feedback to ensure readiness and compliance with 21 CFR 820 and other applicable FDA regulations. - Remediation & Corrective Action Plans
Whether triggered by FDA Form 483 observations or internal audits, our experts specialize in executing robust remediation strategies and CAPA programs. We help clients address compliance gaps, document effective responses, and navigate follow-up communication with FDA review teams.
Through our unwavering commitment to regulatory excellence, RegHelps continues to support manufacturers in building a strong compliance foundation, reducing regulatory risk, and accelerating time-to-market.
We support following manufactures and standards
service related FAQ’s
Yes we provide Food, Cosmetic, Drug and cosmetic label review service.
https://www.fda.gov/medical-devices/overview-device-regulation/device-labeling
https://www.fda.gov/drugs/development-resources/labeling-information-drug-products
The drug Master Files are divided into 4 Types
Type I: Manufacturing Site, Facilities, Operating Procedures, and Personnel
Type II: Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
Type III: Packaging Material
Type IV: Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
Type V: FDA Accepted Reference Information
We provide US Agent service and E copy submission service. We also help with DMF preparation.
