Choosing a good consultant can be tough. There is a lot of details to consider, especially when it comes to guidance on regulatory compliance and validation. Quality assurance and Regulatory affairs are an important aspect of any product development in the pharmaceutical industry. Proper management of SOPs, CAPAs, records, and processes is challenging even with the right experience and proper knowledge. Small holes in the QMS design can create major non-conformances in the future. But how to choose the right advisor for your Pharmaceutical product lifecycle?
Choosing a Pharmaceutical Consultant
First, it’s important to create a list of problems that you need help with. This will allow you to properly consider the specializations that your consultant needs to have.
One of the major regulatory guidelines in the pharmaceutical business is GxP. The term stands for Good X Practices. The X is a variable that changes based on the specific application (GCP – Good Clinical Practice). GxP specialized consultants are usually able to provide guidance on GCP, GMP, and GLP. On the other hand, if you need counsel on a specific application like Good Review Practice (GRP) then it’s a good idea to seek consultants that are GRP specialized. The GxP regulations are regulatory guidelines that ensure the products are safe and meet all requirements for their intended use. Furthermore, FDA 21 CFR Part 11, or ISO 9001:2015 are additional regulatory obligations that you might need to consider based on the nature of your project.
Although proper specialization is essential it does not guarantee a good consulting experience. The language, availability, or time-zone of the consultant are important factors that might slow down your processes during crucial moments. Remote consultants have their pros and cons and it’s important to consider your needs and decide what suits you the best. The last aspect to consider is the experience of the consultant and their previous clients. Some consultants may be used to work with bigger companies. That might not be ideal for the cost-saving mindset of a start-up.
Now that you can imagine your perfect consultant, how do you find one? More importantly, how can you be sure that they deliver a high-quality service?
We created a list of top pharmaceutical consulting firms that provide a high-quality service in their respective specializations.
Top Pharmaceutical Consulting Firms
Paul R. Palmer
Country: United Kingdom
PharmaMedic
Country: United Kingdom
AlfaNordic
Country: Denmark
ARQon
Country: Singapore
X4 Life Sciences
Country: United Kingdom
MedReg
Country: United Kingdom
Plant Vision
Country: Sweden
Acrapack
Country: Australia
Sigma
Country: Sweden, Denmark
Borgensgaard Consulting
Country: Denmark
Quality Systems Now
Country: Australia