Dossier Preparation & Submission

Expert Dossier Preparation & Submission with QxP Pharma Consultants
Are you looking for expert dossier preparation and submission services for pharmaceutical products? QxP Pharma Consultants is a leading provider of GMP consulting and regulatory services in India, ensuring seamless registration and compliance for your pharmaceutical formulations across global markets.

Compilation of CTD/eCTD Dossiers: We expertly prepare CTD and eCTD dossiers, ensuring full compliance with global regulatory standards.
Preparation of ANDA/NDA/MAA Submissions: We assist in preparing and submitting ANDAs, NDAs, and MAAs for regulatory approval and compliance.
Preparation of Technical Documents: We create and review technical documents, including stability studies, analytical method, and process validations.
Regulatory Gap Analysis: We conduct thorough gap analyses to identify potential compliance issues and provide actionable recommendations.
Liaison with Regulatory Authorities: We act as your liaison with regulatory authorities, facilitating seamless communication and addressing any queries.
Post-Approval Variations & Renewals: We manage post-approval variations and renewals, ensuring continued compliance and market access.
GMP Services: As a full service QxP Pharma Consultants in India company we also offer GMP related services.

Benefits of Choosing QxP Pharma:
Expert Guidance: Our team of experienced regulatory consultants provides expert guidance throughout the entire submission process.
Reduced Time-to-Market: Our efficient services help you accelerate your drug approval timeline.
Cost-Effectiveness: We offer competitive pricing and transparent project management.
Confidentiality & Security: We prioritize the confidentiality and security of your sensitive information.
Local Expertise, Global Standards: As a Pharma Consultant in India, we have strong local expertise, while maintaining global regulatory knowledge.

Pharma Regulatory Consulting & GMP Services in India
As one of the top pharma consultants in India, QxP Pharma offers a full spectrum of regulatory consulting and GMP compliance services, including:
GMP Audits & Compliance Training
Regulatory Affairs Consultation for Drug Approvals
Pharmaceutical Product Lifecycle Management
CMC (Chemistry, Manufacturing, and Controls) Documentation Support
Pharmaceutical Technical Writing & Quality Assurance Services

Contact QxP Pharma Consultants in India today for reliable and efficient dossier preparation & submission services in India.

Expert Dossier Preparation & Submission with QxP Pharma Consultants