No pharma company can think of in the business for a long time unless it has full support from pharmaceutical industry consultants.

Most companies thinking of establishing a manufacturing setup have little idea about how to control various aspects of pharma business. It’s left to a professional pharmaceutical consultant who guides a company in different aspects of pharma business. Such consultants are professionals with long experience in almost every field of pharmaceutical. They understand the needs of a company and chalk out the most effective strategy for a company. 

A pharmaceutical consultant helps in following areas:

Checking overall quality

One of the key responsibilities of pharmaceutical industry consultants is to ensure the quality and safety of pharmaceutical products. To achieve this , the pharmaceutical Consultant will have to establish quality control systems and provide expertise on Quality Management Systems and Good Manufacturing Practices.

Helps in getting Market access:

Pharmaceutical industry consultants help in developing market access, pricing models, and reimbursement strategies to help companies launch their products to market successfully. They also guide companies in deciding about the right time to launch a product in the market besides choosing the most appropriate market. A product may be very good but the timing plays a very important role in their success and a pharmaceutical consultant provides that crucial information.

Developing business strategy:

One of the key responsibilities of a pharmaceutical consultant is to help companies in developing business strategies including the preferred products to develop. In the absence of an effective business strategy, pharma companies will be clueless as to what kind  of products will be successful in the market.There are a lot of products that are cheaper if imported from abroad. It doesn’t make sense for a company to manufacture that kind of product.

Pharmacovigilance:  

Once it comes into the market, the safety of pharmaceutical products is essential. This is where pharmaceutical consultants help with risk assessment, adverse event reporting, and safety signal detection.

Market Research and Analysis:

Conducting market research and competitive analysis to identify market trends, opportunities, and potential challenges is a common role. A Pharmaceutical industry Consultant helps companies make informed decisions based on market research.

Supply Chain Management:

Pharmaceutical industry consultants are also responsible for Optimizing supply chains for improving efficiency and reliability. They help with supply chain design, logistics, and inventory management.

Product Development and Innovation:

One of the critical roles of a pharmaceutical consultant is to advise on research and development strategies, drug discovery, and innovation.A consultant is able to give insights about what type of product a company needs to develop and how it should be different from similar products.

You must have realised the importance of pharmaceutical project consultants for companies in the field of healthcare. A company can have all kinds of resources like finance,land, technology and well trained professionals but unless they have a very good pharmaceutical consultant to guide them, it will be very difficult for them to succeed in the highly competitive market. This is why such consultants are considered essential for companies dealing in healthcare and pharmaceutical products.

Expertise in getting Market access: 

Pharmaceutical industry consultants help in developing market access, pricing models, and reimbursement strategies to help companies launch their products to market successfully. They also guide companies in deciding about the right time to launch a product in the market besides choosing the most appropriate market. A product may be very good but the timing plays a very important role in their success and a pharmaceutical consultant provides that crucial information.

During any new drug product development phase, developers have to conduct a degradant and impurity evaluation at varying degrees and several points in the program. An expert pharmaceutical consultant can help in this examination like active API identification as the drug product and substance. Global regulatory agencies like the FDA (Food and Drug Administration) expect recognition, qualification, and reporting of the compounds. It is dependent on the 3 guidance documents by the ICH.

A pharma consultant takes the help of these documents at various developmental stages and addresses particular concerns related to specific degradants or impurities. How and when the pharmaceutical consultant will implement the appropriate timing of the guidance documents is crucial for ignoring obstacles. It is also essential for successful product development for derailing or delaying the program.

What are the impurities in the new drug products or substances?

ICH Q3B (R2) indicates the new degradants in the drug products, and ICH Q3A (R2) indicates the impurities in the drug substances. These guidelines help in ignoring the obstacles before market approval of the drug. It further assists in extensive procedure changes, safety qualification efforts, or product reformulation. 

ICH Q3B and ICH Q3A help in outlining the expectations for identifying, reporting, and qualifying degradants and impurities. The degradants and impurities that exceed the qualification limit or are not properly tested are identified in this development phase. A pharma consultant helps in qualifying the degradants and impurities safety as a group. 

What are the degradants and Impurities Present in 505 (b) (2)?

Most of the development process in 505 (b) (2) is often accelerated. Thus, it becomes essential to be aware of the identified and potential issues in this phase. A reputed pharmaceutical consultant will make sure that the available information is enough for qualifying degradants or impurities. If any degradants or impurities are present in the new drug product at an equal or lower level in the representative approved product batches, then it is qualified. 

How does a pharmaceutical consultant control and assess the DNA reactive impurities? 

Another important document guideline that many pioneer pharma consultants follow in small molecular drugs is ICH M7 (R1). It offers a framework to identify, categorize, qualify, and control the mutagenic degradants and impurities for restricting carcinogenic threats. What distinguishes this guidance from ICH Q3B and ICH Q3A is it is applicable in all developmental stages along with the approval phase. 

It primarily concentrates on DNA reactive substances potentially causing cancer. The question and answer segment in this document offers more clarity on implementing and interpreting particular items present in this guidance. According to the TTC (Threshold of Toxicological Concern), if the concentrations of degradants and impurities are above the mentioned level, they should be evaluated and identified for mutagenicity. 

A pharmaceutical consultant also recognizes and considers the impurities that can form. ICH M7 also offers restrictions on PDEs or Permissible Daily Exposures for a particular mutagenic impurities set. These include conducting a bacterial mutagenicity assay to rule out QSAR structure-centric concerns. An expert rule and a statistical-centric model are necessary for validating and complementing the QSAR models. 

FAQ

What is the key role of a pharmaceutical consultant in new drug evaluation?

A pharma consultant advises the drug manufacturers on the pharmaceutical development and sales. They have immense knowledge about the industrial regulations to aid and allow the companies to efficiently deliver medical treatments to those who are in need.

End Thoughts

It is vital to be aware of any degradants or impurities during the drug development to take ideal actions and ensure continued program progress. An experienced pharmaceutical consultant can address the difficulties that arise because of the degradants or the impurities. Their knowledge about regulatory pathways all around the world offers support to the development of high-quality pharmaceutical drugs, QSAR assessment, and impurity qualification.