Pharmaceuticals
From product development, approval, and promotion to successful market launch
Pharma Expertise Consulting accompanies you through the entire drug life cycle. We help you develop, manufacture, and market prescription (Rx) and over-the-counter (OTC) medicinal products. Specifically, we help you obtain approval and conduct clinic trials. Moreover, we provide drug quality management and drug safety. Likewise, we help you promote and position your medicinal products for sale through developing marketing and sales concepts and professional advertising.
For example, we can take over specific areas such as developing advertising brochures, but we can also develop your entire communication strategy including the advertising campaign, brand strategy, and corporate identity, if required.
Likewise, we can facilitate the development of galenic formulations of your product in coordination with our laboratories—or we can manage the entire product launch, from dossier preparation and submission (granting of marketing authorization) to the marketing and positioning concept.
Marketing & Sales
We support you from the product launch (medical marketing, social media marketing, public relations, and trademark applications) to the selection of the appropriate distribution channel.
Regulatory Affairs
Our services include the selection of the appropriate approval procedure (DCP, MRP, CP) to the submission of dossiers to the appopriate authorities (FDA, EMA, BfArM) and maintenance (variations, renewals).
Quality Management (GXP)
Pharma Expertise Consulting supports your quality management, quality control, and quality assurance according to GXP, GMP, GDP, GVP.
Pharmacovigilance
Pharma Expertise Consulting helps you with everything from creating PSUR and evaluating ADRs and SAEs to building complete pharmacovigilance systems.
Pharmaceutical Development
We will locate a contract laboratory with the specific expertise required to develop your desired dosage form, from proof of concept to manufacturing and marketing approval.
Analytics
We take care of pharmaceutical analysis and quality control of drugs in cooperation with our GMP partner laboratories.
Clinical Studies
In cooperation with a CRO, we accompany you as you plan and execute all stages of testing: from preliminary in vitro studies to clinical trials (phases II to IV) according to GCP.
In- & Out-Licensing
Together, we expand your product portfolio and increase profits–with product acquisitions, sale of licenses, and distribution rights.
Import & Export
Pharma Expertise Consulting supports you in the import and export of pharmaceuticals as well as the implementation of regulatory and customs requirements.