SERVICES

We offer an array of services for our clients including the following:

Regulatory Affairs

We assist in developing a strategic plan to navigate the regulatory landscape and maximize the chances of successful product approvals.

We guide companies through the process of obtaining product registrations and marketing authorizations in various countries. We handle all aspects of dossier preparation, submission, and follow-up with regulatory authorities.

We provide up-to-date information and analysis on regulatory changes, guidelines, and requirements, helping companies stay informed and adapt their strategies accordingly. We offer training programs to educate staff on regulatory requirements, compliance, and best practices.

Electronic Submission

Electronic Common Technical Document (eCTD) submissions
Preparation of pre-IND meetings
Assembly and submission of INDs, NDAs, ANDAs, and DMFs (human or veterinary)
Preparation of INDs, NDAs, and ANDAs with a focus on CMC sections
Preparation of annual updates for all submissions to maintain active status

Dietary Supplements/Nutraceuticals

21 CFR Part 111 - CGMP Regulations for Dietary Supplements

Gap Assessment Audits

Preparation for FDA inspections-What does the FDA expect

Compliance for APIs and Finished Products

Corrective and Preventative Action (CAPA) programs and initiatives

At MediPharm International Consultants, we understand the critical role of CAPA in maintaining product quality and compliance. Our experienced team works closely with clients to develop and implememt effective CAPA strategies that drive continuous improvement and mitigate risks. Here's an overview of our CAPA services:

1. CAPA Investigation: Our team conducts thorough investigations to identify the root causes of quality issues, deviations, and non-conformances. We utilize various tools and techniques, such as root cause analysis, to determine the underlying factors contributing to the problem.

2. CAPA Plan Development: Based on the investigation findings, we develop comprehansive CAPA plans that outline the necessary corrective and preventive actions to address the identified issues. These plans are tailored to the specific need of each client and consider regulatory requirements and industry best practices.

3. CAPA Implementation: We assist in implementing the identified corrective and preventive actions, working closely with you team to ensure effection execution. Our experts provide guidance on procecc improvements, documentation updates, training needs, and any other necessary actions to address the identified issues.

4.CAPA Documentation and Reporting: We help establish robust monitoring systems to track the effectiveness of implemented CAPA actions. This includes defining appropriate metrics, conducting periodic reviews, and making adjustments and compliance.

5.CAPA Documentation and Reporting: We assist in documenting all CAPA activities, including invesigations, action plans, implementation details, and monitoring results. Our team ensures that the documentation meets regulatory requirements and can be readily abailable for audits and inspections.

6. CAPA Training: We offer training programs to educate your staff on CAPA principles, tools, and techniques. This helps build a culture of quality and continuous improvement with your organization.

Preventative Action

Identify and correct GMP deficiencies proactively, and develop CAPA initiatives
Evaluate Quality Systems (QA/QC)
Evaluate Document Control System, including SOPs, Master Production, Packaging, and Analytica
Testing and Specification Records

Evaluate Equipment Qualification, Process, Analytical, and Cleaning Validation Protocols and Reports
See Corrective Action above

Audits

Preparation for FDA and MHRA Pre-Approval Inspections
Preparation for Client Audits
Audits and qualifications of key vendors, i.e. manufacturers of APIs (drugs and dietary ingredients), key starting materials, unique excipients, finished dosage forms, components, and contract testing laboratories
Audits of clinical research organizations, clinical sites, and depots
Monitoring of CRO projects

Quality Systems

Quality Assurance oversight
Establishing Quality System documents and control systems

Preparation of Standard Operating Procedures (SOPs)
Preparation of Quality Manual
Preparation of Quality/Vendor Agreements

Due Diligence

Audits of manufacturing sites for compliance with pertinent FDA GMPs, and other requirements
Review of NDAs, ANDAs, and Drug Master Files for confirmation of status, and compliance with FDA requirements
Review of the status of Vendor Qualifications of manufacturing sites for active pharmaceutical ingredients, key starting materials, unique excipients, and all finished product dosage forms

DEA Systems

Evaluation of Security System designs
Audits for existing or planned facility design
Compliance audits
SOP Manual for Handling Controlled Substances
Training of R&D, analytical, production, Quality, and warehouse personnel in handling and accountability of Controlled Substances

Training

At MediPharm International Consultants, we provide comprehensive training programs to support the development of pharmaceutical professionals and enhance their skills and knowledge in various areas of the industry. Our training offerings are designed to meet the specific needs of individuals and organizations, ensuring that they stay up-to-date with the latest regulations, industry best practices, and emerging trends.

Here are some of the training programs we offer:

Good Manufacturing Practice (GMP) Training: We provide GMP training to help organizations ensure compliance with regulatory requirements and maintain high-quality standards in their manufacturing processes. Our training covers topics such as GMP principles, documentation and record-keeping, quality management systems, and risk assessment.
Quality Management Systems (QMS) Training: Our QMS training programs focus on helping organizations establish and maintain effective quality management systems. We cover topics such as quality planning, process control, risk management, change control, and auditing techniques.
Regulatory Compliance Training: We offer training programs to help pharmaceutical professionals understand and navigate the complex landscape of regulatory requirements. Our training covers topics such as regulatory submissions, post-approval compliance, inspections and audits, and pharmacovigilance.
Data Integrity Training: Given the increasing importance of data integrity in the pharmaceutical industry, we provide training programs that focus on best practices for data management, data integrity controls, and ensuring the reliability and accuracy of data throughout the product lifecycle.
Good Clinical Practice (GCP) Training: For professionals involved in clinical research, we offer GCP training to ensure adherence to ethical and scientific standards in the conduct of clinical trials. Our training covers topics such as study design, participant recruitment and consent, data collection and analysis, and reporting of adverse events.
Leadership and Soft Skills Training: We recognize the importance of leadership and interpersonal skills in the pharmaceutical industry. Our training programs help individuals develop skills such as communication, problem-solving, teamwork, and decision-making, enabling them to excel in their roles and contribute to organizational success.

Our training programs can be delivered in various formats, including classroom training, e-learning modules, workshops, and customized on-site training sessions. We work closely with our clients to understand their specific training needs and tailor our programs accordingly.

Sourcing

Sourcing of APIs, finished dosage forms, equipment, and analytical services
Verification of source capabilities, FDA regulatory history
Verification of status of DMFs for APIs
Verification of NDAs, ANDAs for finished dosage forms

Project Management

Clinical trial material logistics and operations management
Work with contract research organizations to meet clinical timelines
Prepare and manage integrated project timelines
Liaison between organizations

As needed for a client’s project, we also have an extensive network of global professionals who can avail their skills in matters of facility design, equipment and processing design, and project management to support your program(s).