Michael Sassano & Antonio Guedelha: GMP #14 Client Management in GMP

Authored By: Michael Sassano & Antonio Guedelha 
 

Michael Sassano

Founder, Chairman & CEO Somai Pharmaceuticals -Investor, Cannabis, GMP, Pharmaceutical &Herbal Medicine https://www.linkedin.com/in/michaelsassano3/  
 

Antonio Guedelha

  Pharmaceutical cannabis companies with industrial manufacturing facilities operate in a global market and can cater to a broad range of potential clients. You can sell cannabis products to the Active Pharmaceutical Ingredient (API) markets, finished products can be white labeled, and branded finished products can be sold to pharmacies. You can also engage in contract manufacturing. The main differences between these options are whether you sell to pharmacies or other companies.   

Selling to Pharmacies

Pharmacies carry multiple different forms of pharmaceutical products. Branded products are labeled with the brand name of a medication, while generic products are labeled according to the APIs. Prescription products must be prescribed by a doctor or medical provider, while over-the-counter (OTC) products do not require a prescription.  Although these products cannot be marketed to the general public, your sales staff must still reach the doctors who prescribe these medicines and the pharmacists who deliver them. Doctors must be convinced of the efficacy of your branded products, and pharmacists need to be educated about your generic products.  The documentation required in the pharmaceutical industry is extensive. All documentation provided to doctors, pharmacists, and consumers must comply with the applicable laws and agencies. Regulatory affairs officers or a qualified Contract Research Organization (CRO) typically analyze and prepare these documents.  

Branded Products

Branded products sold to pharmacies are highly regulated and require a significant investment. Prescription drugs are controlled by regulative organizations such as the Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) in Europe. Depending on the drug, branded pharmaceutical products can be sold without a doctor’s prescription.   

Generic Products

Generic products are recommended based on their active pharmaceutical ingredient (API). Pharmacies have some discretion when presenting generic products to patients, especially if the doctor has not indicated a preference.   

OTC

Country authorities also control OTC drugs as pharmaceutical drugs. These agencies also regulate the marketing and media allowed for OTC. The general rule is that advertising claims must be truthful, not misleading or unfair.  

Selling to Other Businesses

There are also rules and regulations to follow when selling to another company. Good manufacturing practice (GMP) standards impose proper protocol for both buyer and seller. The most critical areas to watch are media information, client marketing pieces, new product procedure for clients, and customer relationship management (CRM) compliance.   

Marketing and Customer Management

You can advertise your services through regular media channels such as newsletters, flyers, and emails that comply with privacy protection and other requirements. You can also promote your services and products at exhibitions. Your salespeople should regularly visit clients and provide marketing services as well.   

Contract Manufacturing

Before you sign an agreement with a new contract manufacturing client, you must ensure the product can be manufactured in your installation. This should be part of your GMP system’s standard operating procedures (SOPs). There are several components of this compliance: 
  • You must ensure the origin of the API and that your regulators approve the supplier
  • Check that your facility has the authorization to manufacture that product
  • Verify that your client has the necessary licenses to sell the product
  • Confirm your client has given you the complete dossier of the approved product 
Regulators require the use of  CRM software. CRM software tracks and manages interactions with customers and potential customers. A CRM helps streamline processes, build customer relationships, increase sales, improve customer service, and increase profitability. For sales of pharmaceutical products, you will need to comply with regulatory GMP standards for your CRM, your facility and the processes within. Importantly, your client must also conform with regulatory GMP requirements for you to be able to sell to them.  

Pitfalls and Product Recalls

It is crucial to be prepared, as product recalls can occur. Recalls are unfortunate and may happen due to several reasons. Problems can arise with a raw material that went undetected in the analysis stage because of faulty equipment or an operator error. GMP systems are designed to solve most of these situations, but no system is perfect.  In extreme cases, it may be necessary to make a product recall. This requires that you collect all units of your product from all clients so the faulty products can be destroyed. All of these procedures should be defined in your GMP system.  You will need to lead this operation if the finished product is yours. If the product is your client’s, they must drive this process with your support. The responsible party will pay all recall costs and the costs if someone gets sick from your products. Be sure you have product liability insurance.  

Regulation and Reward

The pharmaceutical products marketplace is highly regulated. Your sales team must comply with various advertising rules, and both you and your B2B clients must also comply with regulations. You must be ready to address any foreseeable situations, such as recalls. Being an active player in the pharmaceutical cannabis industry can be incredibly difficult, but it can also be hugely rewarding on a personal and financial level.