Regulatory Support

QxP Pharma Consultants: Ensuring Seamless Regulatory Navigation for Pharma, Biotech, and Medical Devices
At QxP Pharma Consultants, we offer comprehensive Pharma Regulatory Support services to help pharmaceutical, biotechnology, and medical device companies meet international regulatory requirements efficiently.
Whether you’re launching a new drug, conducting a clinical trial, or preparing a dossier for a medical device, our experts provide end-to-end regulatory support across the entire product lifecycle.

Your Trusted Partner for Global Regulatory Excellence
With decades of experience and a team of seasoned professionals, QxP Pharma Consultants in Ahmedabad have become a trusted name for GMP Services Providing in Ahmedabad and GMP Services Providing in India.
Our clients value our ability to simplify the regulatory pathway, avoid delays, and accelerate market access through tailored Regulatory Strategy and Support.
Our expertise spans:
FDA Regulatory Support Services
EU Regulatory Affairs Support
WHO Regulatory Support
MOH Regulatory Support (Ministries of Health in various countries)

1. Regulatory Documentation Support
Accurate and well-organized documentation is the backbone of regulatory compliance. Our team provides full-spectrum Regulatory Documentation Support services including:
Common Technical Document (CTD) preparation
Investigator brochures
Module-wise compilation and review
Summary of Product Characteristics (SmPC)
Risk Management Plans (RMPs)
We ensure that every document aligns with the latest global guidelines, facilitating smooth submission and approval.

2. Regulatory Submission Support
Our Regulatory Submission Support services are designed to assist you in managing submissions efficiently for new drugs, generics, biologics, and medical devices. We handle:
New Drug Applications (NDAs)
Abbreviated New Drug Applications (ANDAs)
Investigational New Drug (IND) submissions
Marketing Authorization Applications (MAAs)
eCTD publishing and validation
By streamlining the submission process, we help reduce delays and increase your chances of first-cycle approvals.

3. Regulatory Strategy and Lifecycle Support
A well-defined regulatory roadmap is essential for product success. Our team offers customized Regulatory Strategy and Supports to align your development plan with global regulatory expectations.
Our Lifecycle Regulatory Supports Services ensure ongoing compliance from clinical development through post-marketing phases, including:
Variations and amendments
Renewals and annual updates
Labeling and packaging updates
We help manage every phase of the regulatory lifecycle efficiently and compliantly.

4. Clinical Trial Regulatory Support
Clinical trials must meet stringent ethical and regulatory standards. Our Clinical Trial Regulatory Supports ensures full compliance with ICH GCP, local ethics committees, and global regulatory bodies.
Our services include:
Clinical trial applications (CTAs)
Informed consent forms (ICFs) and study protocols
Site regulatory document preparation and management
Liaison with ethics committees and health authorities

5. CMC Regulatory Support
Chemistry, Manufacturing, and Controls (CMC) documentation is a crucial component of regulatory filings. We provide CMC Regulatory Supports for:
Drug substance and product development reports
Process validation protocols
Manufacturing site compliance
Analytical method validation and stability data
We ensure your CMC sections are comprehensive, compliant, and audit-ready.

GMP Regulatory Supports
As a core part of QxP Pharma Consultants & GMP Services, we specialize in GMP Regulatory Supports, helping companies ensure compliance with Good Manufacturing Practices during inspections and audits. Our team offers:
Mock GMP audits
CAPA planning and implementation
Facility readiness assessments
SOP reviews and updates

Regulatory Supports for Drug Approvals
Bringing a product to market demands strategic planning and execution. Our Regulatory Supports for Drug Approvals includes:
Pre-submission meetings with regulatory authorities
Dossier preparation and submission
Response to deficiency letters and RFIs
Post-approval compliance activities

Medical Device Regulatory Supports
For manufacturers of devices, we offer complete Medical Device Regulatory Supports, including:
Device classification and registration
Technical file and design dossier preparation
CE marking and FDA 510(k) submission
PMS and vigilance reporting

Pharma Consultants in India You Can Trust
As one of the top Pharma Consultants in India, QxP stands apart by delivering:
Customized, cost-effective solutions
In-depth knowledge of global regulatory frameworks
Proactive project management and communication
Strict adherence to timelines and quality
We serve clients across generics, branded drugs, biosimilars, vaccines, APIs, and medical devices.

Why Regulatory Compliance Matters?
Failure to comply with regulatory guidelines can lead to:
Delays in product approvals
Costly recalls and rework
Legal penalties and reputational damage
Loss of market share
Partnering with QxP Pharma Consultants ensures you’re always a step ahead in achieving full regulatory compliance.

Get in Touch with QxP Pharma Consultants
Are you looking for Pharmaceutical Regulatory Supports that guarantees compliance and accelerates your time to market?
Contact us today to learn how our Regulatory Affairs Support Services can support your success in a regulated market.
Partner with QxP — Where Regulatory Excellence Meets Industry Experience.

QxP Pharma Consultants: Ensuring Seamless Regulatory Navigation for Pharma, Biotech, and Medical Devices