How to Choose a Reliable EU GMP Consultancy Service ?

When deciding to build a new facility or upgrade an existing one to comply with EU-GMP standards, selecting the right EU GMP consultancy service is crucial. You need a partner that not only possesses the necessary knowledge, experience, and capabilities but also has the ability to activate inspections, register products, and support sales in Europe. However, this process often presents several challenges:

• Lack of information and references: It can be difficult to find experienced and reputable consultants. Many firms may not have the necessary capabilities or may exaggerate their abilities.
• Quality variations: The quality of consultancy services can vary greatly. Some consultants may lack sufficient experience or a thorough understanding of detailed EU GMP requirements.
• High costs: EU GMP consultancy services are often expensive due to the complexity and level of detail involved in such projects. This can be challenging for small and medium-sized enterprises.
• Language and cultural barriers: If the consultant is unfamiliar with Vietnamese working practices and culture, communication issues may arise and misunderstandings may occur during interactions.
• Time and commitment: Consulting and implementing EU GMP processes require time and long-term commitment from both parties. A lack of consistency and commitment from the consultant can lead to delays and project failures.
• Keeping up with new regulations: EU GMP regulations are frequently updated and changed. Consultants must stay up-to-date and have a thorough understanding of the latest regulations to provide accurate advice to businesses.

So how can you find and select a suitable EU GMP consultancy service? Let’s explore some key considerations when choosing a reliable EU GMP consultancy service through the following article.

1. Choose a EU GMP consultancy service with a proven track record of successful projects in Vietnam and Asia:

• Consultants with a successful track record in Vietnam and Asia will quickly understand your specific challenges and provide tailored solutions.
• Pay attention to the dosage forms and production lines the consultant has experience with. Avoid working with partners who have not successfully consulted on the specific formulation or production line you are planning.

2. Evaluate the consultant’s actual capabilities:

• Choose a consultant that can act as a Marketing Authorization Holder (MAH) in Europe: To be an MAH in Europe, the firm must have a physical presence in Europe (distribution system, pharmacovigilance system, etc.).
• Evaluate the company’s establishment time and professional expertise.
• Assess the consultant’s financial capacity.
• Evaluate the personnel, especially quality experts. Ensure that the consultant has employees who have worked in reputable pharmaceutical companies and have a deep understanding of EU-GMP. Ask challenging questions to test the consultants’ advisory capabilities. A strong consultancy team should have a full complement of experts in RD, QA, QC, production, engineering to support you.
• Refer to customer reviews: Collect reviews and feedback from previous clients to get an overview of the service quality. Be sure to ask for information from multiple sources to ensure objectivity.
• Evaluate the consultant’s relationship with regulatory authorities in Europe. If the consultant has a good relationship and a thorough understanding of the operations of regulatory authorities, the inspection activation process can be carried out on schedule.
• Evaluate the ability to support product distribution in Europe: A strong consultant can help you sell products to Europe with a guaranteed volume in the early years, which is an important plus. You may only want to have a bidding advantage domestically, but regular exports to Europe will build your brand and ensure the success of subsequent re-evaluations.
• Comprehensive services: Choose a consultant capable of providing services from initial assessment, design, quality system development, product registration, inspection activation, to product distribution in Europe.
• Ability to update knowledge: Strong consultants have employees who are regularly trained and proactively update the latest changes in regulations and EU guidelines.

3. Clear quotation and quality commitment:

• Detailed and clear quotation: Request a detailed quote that includes all costs, avoiding unnecessary additional costs. Through the quote, you can assess the consultant’s capabilities. Inexperienced firms will not be able to provide a complete and detailed quote.
• Commitment to quality of work: The consultant should commit to the quality of work with specific results for each stage.
• Commitment to completion time: Ensure there is a clear timeline for important milestones.

4. Communication skills, project management, integrity, and support:

• Project management skills: If a consultant only has professional expertise but lacks project management skills, they are not a true consultant.
• Clear and effective communication: Choose a consultant who can communicate effectively with clear and transparent information. Consulting experience is evident in the ability to quickly understand the client’s issues and present information in a simple and easy-to-understand manner.
• Honesty and integrity: Professional consultants will always focus on building a robust quality system. Without honesty and integrity, this cannot be achieved.
• Ability to work well in a team: The consultant needs to work well with your internal team and partners.

Choosing the right EU GMP consultancy service will not only help you achieve EU-GMP compliance with optimal resources and time but also help you build a robust quality system, optimize your processes, enhance your team’s capabilities, minimize risks, reduce investment costs, and enhance your competitiveness in the European market. With the support of a professional and experienced consultant, your project will have a higher chance of success, bringing long-term benefits to your business.

These are the points you should consider when looking for a reputable EU GMP consultancy service. If you are still having difficulty choosing a suitable consultant, please refer to SEN Pharma’s EU GMP consultancy services or contact SEN Pharma (086 918 0917) for support.