Studio Pharma
A Vanguard of One-Stop Pharmaceutical Consulting

A nimble player in the Benelux pharma consulting landscape, Studio Pharma punches above its weight, matching the prowess of industry behemoths—thanks to its razor-sharp focus on specialised regulatory matters and a formidable team of experts.

Studio Pharma serves as a one-stop shop for pharma and biotech companies seeking guidance in a wide range of areas. These include consulting for medical devices, particularly under the new MDR legislation, pharmacovigilance, registration of medicinal products and ways to navigate the intricate pathways of post-commercialisation activities like pricing, reimbursement and promotional review.

Founder and Managing Director Isabelle Geeraert leads the charge of Studio Pharma’s expertise. Her extensive experience in the sector is a major asset, equipping her proficient team with the insights and skills to efficiently launch a pharma or medical product in the market.

As Isabelle puts it, “Clients often come to us saying, ‘We have a plan to launch a new product in the Benelux countries. Could you help us with a timely launch?’ And that’s exactly what we do. We take up the challenge and handle everything necessary to make it happen.”

Most notably, the company plays a pivotal role in the commercialisation and marketing aspects of pharmaceutical products.

Every pharma company can resonate with the importance of this service. Often, a pharmaceutical company is ready to market an exceptional product. They have set a competitive price, secured reimbursement agreements and prepared to distribute to key account managers, healthcare professionals (HCPs) and hospitals. However, if these HCPs cannot locate the product in their prescription databases, it can’t be sold.

This scenario often arises from a missing link in the distribution chain, resulting in costly delays. The product remains non-prescribable until the issue is resolved.

Studio Pharma adeptly synchronises the launch plans, launch teams, and various databases to ensure the product’s sale starts at the planned launch date.
This meticulous alignment is just the beginning. The nuances of commercialisation in the Benelux region demand strict adherence to legal mandates, such as appointing a ‘Responsible Person for Information’ to oversee promotional materials. Studio Pharma has both the expertise and legal credentials to attend to these stringent standards.

The company’s role also extends to compliance and transparency, a cornerstone of the European Sunshine Act, which calls for clarity from pharmaceutical firms about their financial engagements with healthcare entities. Studio Pharma manages these details, enabling companies to seamlessly track, evaluate, and disclose their financial interactions.

Quality is another cornerstone of Studio Pharma’s service offering. The company establishes quality management systems for distributing and selling medicinal products, an essential requirement for any entity looking to market pharmaceutical products within the framework of Good Distribution Practice (GDP).

The team’s expertise in crafting standard operating procedures (SOP) forms another aspect of their wide-ranging competence. It is a job many shy away from, but at Studio Pharma, it is approached with a seasoned hand. Adhering to the Keep It Simple and Straightforward (KISS) principle, the company has streamlined this process over two decades.

Through numerous projects with diverse clients—national and international, and large and small—Studio Pharma has perfected its ability to draft SOPs in a way that anticipates potential issues and addresses them before they can impact the project’s progress.

Studio Pharma’s SOP writing in all of Belgium’s official languages—German, Dutch, and French—further adds to its strategic advantage.

The company’s edge is constantly sharpened by its team’s relentless pursuit of the latest industry developments. They maintain a keen eye on updates from regulatory bodies and remain actively involved in industry group organisations. Their presence at meetings and analysis of sector-specific newsletters are more than routine; they are integral to the company’s regulatory intelligence strategy to help clients stay abreast of regulatory shifts.

These connections recently proved invaluable in tackling the stock shortage of a specific medicinal product.

Belgian authorities, aware of Studio Pharma’s role as the regulatory consultant for a particular company, approached them with a request. They highlighted the persistent stock shortages of a product and noted one of Studio Pharma’s clients possessed the marketing authorisation for a product with a similar active ingredient but wasn’t selling it in the market.

While the client was open to entering the Belgian market, it insisted on pricing parity with France—where the product was already available. This presented a challenge, as Belgian pharmaceutical prices are typically lower. On behalf of the pharma company, Studio Pharma embarked on negotiations with three distinct Belgian regulatory bodies—covering registration, pricing, and reimbursement. This led them to achieving a deal where the product’s price in Belgium was only five percent lower than in France.

This resolution is a testament to Studio Pharma’s footing in the domain and commitment to serving both client interests and the public good.

Such an impact can only be made by a team of dedicated workers and a culture of continuous learning. The team systematically documents client inquiries and challenges, creating a comprehensive database that hones their problem-solving strategies.

This knowledge repository serves as Studio Pharma’s ‘secret sauce,’ empowering them to consistently go the extra mile in the pharma consultancy arena.