GMP Consultant
Our experts are addressing professionally and efficiently your various and demanding GMP requirements. We are able to offer individual niche solutions for your challenges as well as comprehensive packages that cover all your GMP requirements.
For start-ups, we provide the implementation of a quality management system with all mandatory documents (GMP & GDP). Furthermore, our team support the GMP-compliant definition of process steps and implementation with regard to rooms and equipment (GxP QMS, GAP Analysis, Qualification & Validation). With us, you obtain your manufacturing authorization and the corresponding GMP certificate within the shortest possible time and move your business idea forward as quickly as possible.
Plant Up-Gradtion
If you already have the API or Formulation Plant which is approved by the local regulatory authority and if you want to expand your reach to regulated territories like USFDA, EMEA, MHRA, PIC/S, WHO etc. then you may choose for Plant Up-gradation Service.
Plant Up-gradation Includes the following:
Establishment of Proper scope for which regulation is being targeted
GAP Audit of Existing Plant (API/Formulation)
Preparation of GAP Audit Report
Preparation of CAPA Plan
Identification of GAPs and making time bound milestones for up-gradation
Validation
SOP and Procedures up-gradation
Training
QMS system establishment/ restructuring as per requirement
Internal Audit System development
Training: Our qualified & experienced Trainers provide training on all GXP topics like GMP, GDP, GLP, Data Integrity, QMS and many other critical topics which helps to enhance employees skill and operational performance
AUDITS: Independent Supplier Audit (GMP System and Facility Audit)
To evaluate the system and manufacturing facility in compliance with the regulatory expectation and quality standards. To ensure the capability of the facility to manufacture quality medicine. To determine the effectiveness of the Quality system implemented and adherence to the specified quality objectives.
- Vendor qualification/assessment Audit
- Remote Audit / Virtual Audit
- Pre-Inspection Audit
- GAP Audit
- QMS Audit
REGULATORY
We Curedose Pharmaceutical Consultants (CPC) provides Dossier preparation and submission service. We provide innovative, cost-effective, and creative graphic design & artwork services to support new product launches and brand re-designs. Our artwork management team deals with artwork management of any product including leaflet, carton, and label.
We also offer artwork services for content to carton, labeling and primary and secondary packaging, which include all printed materials associated with the products e.g., containers, cartons, foils and inserts etc. CPC has an unsurpassed reputation for excellence in technical, regulatory consulting, and guidance services for the Pharmaceutical Industry, including generic and new drug products, OTC, and monograph drugs, and many more.
CPC is proficient in the development, implementation, and management of diversified projects involving compliance, scientific principles, technical aspects, and regulatory requirements related to pharmaceutical products.
QUALIFIED PERSON (QP)
We Curedose Pharmaceutical Consultants (CPC) provides the highest standard of Qualified Person (QP) services in the pharmaceutical industry.
We provide experienced QP resource to conduct routine QP activities such as contract QP services for both Commercial and IMP products and batch certification etc. More importantly we can partner our QP expertise with you to make your firms business and quality management systems inspection ready, efficient and effective.
MarYop Pharmaceuticals Consultant as Subsidiary of Curedose Pharma Labs
