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FDA Pharmaceutical Compliance Services

FDA Pharmaceutical Compliance for Generic Drug Companies

Our FDA Pharmaceutical Compliance service line enables you to get your products to market quickly and to maintain your FDA compliance status. mdi Consulstants have helped hundreds of companies to achieve and maintain their FDA Pharmaceutical compliance.

FDA Approved

Bring Your Generic Drug to Market with FDA Pharmaceutical Compliance

mdi Consultants has a proven track record of helping hundreds of Generic Drug companies bring their product to market quickly and successfully, while maintaining FDA Pharmaceutical Compliance.

Below, is a list of our specific service offerings.

Our job is to get your products to market quickly, under FDA compliant status.

Product lifecycle

Pharmaceutical Product lifecycle

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mdi’s Consultants FDA Regulatory and Strategic Planning Services for Pharmaceutical Companies

Clinical Trial Management for Pharmaceuticals

mdi’s services include developing you Pharmaceuticals’ clinical protocol, setting up and interacting with the IRB (Institutional Review Board), recruiting, working with the investigator, monitoring the trials, data gathering and analysis, project management, and statistical analysis.

Abbreviated New Drug Application (ANDA) Submission Services for Pharmaceutical Companies

An ANDA is a required application for Generic Pharmaceuticals, which must be sent to the FDA in order to market a product, once the parents of the Brand Name drug expire.
Here is the procedure.

  1. Determine which Brand Name drug you are equivalent to.
  2. Determine what bioequivalent testing is required.
  3. Prepare the ANDA application.
  4. Pay the FDA user fees.
  5. Submit the Abbreviated New Drug Application (ANDA).
  6. Assist with any FDA questions.

Drug Master File ( DMF ) Submission Services

A DMF (Drug Master File) is a file submitted to the FDA, which includes technical, clinical, and safety information about a pharmaceuticals component or material. If you are a component maker, your customers may desire a DMF from you.
mdi guides clients through the entire application preparation and submission process.

FDA Quality System Strategy

Assuring FDA compliance to the cGMPs requirements for Pharmaceuticals is critical for all drug companies and is a part of the FDA Quality Systems Strategy. The quality system requirements are defined by cGMP — Current Good Manufacturing Practices, 21CFR, Part 211— the guidelines which are specified by the FDA.

Quality System Implementation

  • The 5 key elements to a quality system for Pharmaceuticals are: quality manual, quality procedures, work instructions, product quality plans and production level quality records. mdi helps you to prepare and implement the entire system for FDA cGMP (Current Good Manufacturing Practices) compliance.
  • We supply you with a high-quality fully FDA compliant quality manual and procedures customized and implemented for your operation. Our solutions include management review, Master Batch Record, Vendor control, Employee requirements, Corrective Action/Preventive Action (CAPA), and complaint handling. The manuals and procedures are easy to read, follow, and are both electronically and paper-based.
  • Work instructions, product quality plans and production-level quality records are completely unique to each company, we work with you to ensure you are FDA compliant.

cGMP Audits for Pharmaceuticals

  • Performing a mock FDA audit of your operations is to determine compliance to the cGMP (Current Good Manufacturing Practices).
  • The audit would be performed in similar manner to an FDA audit and will be performed by former US FDA field investigators or Senior consultants with extensive Pharma experience.
  • These mock audits serve two purposes: testing your quality system and providing recommendations for corrective actions.

Employee Training / Internal Auditor Training

  • mdi Consultants provide FDA cGMP employee training and internal auditor training.
  • Our in-house training sessions include all aspects of FDA regulatory and quality system requirements including cGMP compliance, Process Validation, Sterilization Validation, FDA strategic Planning, dealing with FDA inspections and how to prepare replies to FDA 483 and Warning Letters.

FDA Liaison

Because FDA inspections can be one of the most trying times in dealing with the FDA, knowing what to expect, interpreting the FDA findings, and providing immediate solutions to prevent regulatory actions is critical to the survival of a company.

mdi Consultants provide ongoing support to let you to work together with our experts throughout the year. With our Liaison Service, when an FDA event occurs or a question arises, we are there to help you. We can deal with:

  • FDA inspections.
  • Responses to the 483.
  • Responses to the W/L