Regulatory Services (Regulatory Affairs & Compliance)
Dossier Compilation
Pharmapodium will work closely with the drug company to collect and organize all the relevant data and documents, including pre-clinical and clinical trial data, manufacturing and quality control information, and marketing and labeling materials. Our goal of this process is to create a Comprehensive Document, known as a Regulatory Dossier, that includes all the necessary information required to obtain approval from Regulatory Agencies to market and sell a drug.
Render the following Services
- Common Technical Dossier (CTD) Guideline
- Asian Common Technical Dossier Guideline (ACTD)
- Electronic Common Technical Dossier (E-CTD) Guideline
- Country Specific
Dossier Submission
“With our dossier compilation and submission services, you can ensure regulatory success. Prove Your Pharma’s Best with Our Expert Support and Guaranteed Approval.”
Dossier Compilation Submission for
- Asia
- Africa
- South Africa
- Middle East Countries GCC
- CIS Countries
- Central America
- North America
- Europe
- U.S
Variation Filling
Bringing knowledge and experience to the process of filing variant filings, assisting businesses in navigating the complicated regulatory environment and ensuring that their products continue to be compliant with current standards. As a result, businesses may be able to promote their goods more swiftly and effectively while maintaining the high standards of patient safety, efficacy, and quality.
Drug Master File
We provides services to regulatory agencies that contains confidential, detailed information about the facilities, processes, or articles used in the manufacture, processing, packaging, and storage of a drug product. We provide support in the approval of a drug product and to provide regulatory agencies with necessary information while protecting the confidential information of the submitter.
Regulatory Compliance
We provide guidance on the Regulatory requirements for specific product types, such as medical devices or pharmaceuticals and help our Clients to prepare and submit regulatory filings to obtain approval for their products.
This may include providing education and Training on the latest Regulatory requirements, assisting with the implementation of new processes and systems, and conducting ongoing monitoring and auditing to ensure ongoing compliance.
Render the Following part
- Regulatory Compliance consulting
- Data integrity management
- Compliance gap assessments and remediation planning
We Provide the Best Services
“We deliver great quality and customer satisfaction via our commitment to excellence and innovation.”