Let our experts design a strategic solution that is tailored to your needs and development goals. Having led many successful efforts with multiple regulatory agencies around the world, PharmaLex can leverage years of professional experience to help move theory into action. We have managed successful development efforts from the initial idea and incubation stage through to getting a new product through approval and providing post-market analysis.
Working with us, will give you confidence in knowing that our expertise will help you reach your goal efficiently.
Development strategy and gap analysis
Having a thorough development plan will help market activities post-launch. PharmaLex will support designing a strategy that will clearly define the end goal, aligned with product attributes and agency requirements. This tandem will determine where to best market and implement a new product. The process commences with a detailed gap analysis and will include periodic regulatory intelligence and competitor monitoring to make sure that the development strategy meets all regulatory requirements. We will document where a deficiency may need to be addressed to ensure the product is meeting all regulatory guidelines throughout the product’s current development process.
Clinical and Non-Clinical trial designs
Working in collaboration with your team, PharmaLex has the knowledge to implement trial designs to achieve optimum results. With a wide-range of experienced and highly competent team members, we create a target label-oriented study design, write study-relevant documents (e.g. test protocols, clinical study reports, Investigator’s Brochure, IMPD) or compile non-clinical and clinical application documents to satisfy all regulatory authority requirements. We are able to provide customized design concepts and services for every project, based on our proven track record of experience and close network with various cooperation partners, especially in the area of GLP- and GCP-compliant studies.
Health authority briefing documents
Critical to the success of products are briefing documents submitted to the regulatory authorities. Our professional experts have extensive regulatory background to prepare a briefing document that will tell your product’s story. A well-written document advocates – on behalf of your team and your product – to address potential review issues as well as to get the agency to understand the potential benefits of your product. These documents need to be scaled to the right audience, containing relevant details and must be easily read and understood – we have the knowledge to prepare the right briefing book for the right audience.
Scientific advice and health authority meetings
PharmaLex and the right strategy: your route to success. Each meeting with health authorities is important for your strategic decision making process. Take advantage of years of experience in the field of scientific collaboration with numerous official bodies throughout the world. We have a long proven track record of preparing scientific advice processes and bringing them to a successful conclusion, which highlights the quality and mutual trust behind our close working relationship with the regulatory authorities.
PharmaLex has a multi-disciplinary team of experts that provides comprehensive services for all kinds of scientific due diligence measures. Our critical appraisal of existing technical, non-clinical, clinical and regulatory documents help to discover not only the strengths, weaknesses and concealed risks, but also market opportunities of prospective licensees. This represents a major contribution to a close scrutiny of the potential partner’s true value that will allow you to make an informed decision based on sound, reliable evidence.
CTD clinical & nonclinical documents
With experience around the world, PharmaLex is prepared to assist in preparing Common Technical Documents (CTD) for both clinical and non-clinical needs. Our experts are able to provide translation services, electronic submissions and comprehensive documentation for submittal to regional regulatory agencies.
Pediatric Investigation Plans / Pediatric Study Plans
Our consultants can author a required Pediatric Study Plan as well as assess if you may be eligible to receive a waiver or deferral from your regional regulatory agency.
Orphan Drug Designations
PharmaLex can provide support with your application for Orphan Drug status, delivering documents for submission to both the EMA and the FDA. The benefit: with only little additional effort, you can apply for recognition of Orphan Drug status for your development project in the EU and the USA. We offer expert advice in preparation for consultation meetings and will accompany you to meetings – if needed. In addition, we provide continued post-approval support, with the fulfillment of approval conditions or the lifecycle management of your product.
Since the introduction of the Tissue (2004) and ATMP (2009) regulatory framework in the EU and the corresponding US framework programs for cell or gene therapy or based products, we specialize in navigating through this highly challenging environment. Due to the rapidly evolving ATMP landscape it’s key to have up-to-date knowledge and expertise to successfully gain and maintain a centralized market authorization. Additionally we offer ATMP-specific workshops/trainings to further support our clients throughout the drug development process.
Environmental Risk Assessment (EU, USA, Canada)
We create Environmental Risk Assessment reports for all product groups of human and veterinary medicines in accordance with regional legal requirements. Our teams of qualified, toxicology experts have extensive experience in compiling ERAs/EAs for a wide variety of active ingredients and will advise concerning the evaluation of environmental risks and take care of professional communication and documentation with the relevant authorities.