CESSY
Www.capeval-pharma.com
I - Home II – Services III - About us IV – Contact V - Press releases and publications VI – Careers
I - HOME
CapEval Pharma: “Taking nothing for granted – Reassessing every turn”
The know-how you need.
CapEval Pharma is an independent company founded in 2010 by Dr. Olivier Loget and providing development, registration as well as teaching services in the fields of animal ophthalmology, pharmaceuticals, veterinary drugs, cosmetics, agrochemicals and chemicals.
The key experience and proficiency of its scientists specialized in various fields of expertise consist of assessment, selection and management of drug development projects, due diligence assistance and implementation, ocular examination, cardiovascular examination, medical writing, scientific translations, public subvention dossiers, fundraising and implementation and development of marketing partnerships.
Our more than 25-year experience in drug development offers an efficient and high quality service to our partners. The accuracy, organization and high standards of information and communication based on modern technologies enable CapEval Pharma to give you the assurance of confidentiality in the investigation and completion of your projects with the vigilance essential to timely, truthful, precise and efficient reporting and submission.
Assisting you in closely managing your objectives makes CapEval Pharma your ideal partner for development of your products by their appropriate assessment taking into consideration the evolving requirements of the international regulatory authorities.
We work in strong collaboration with our partners by implementing a constant and transparent communication with you, ensuring fulfillment of your expectations throughout the course of the project.
We bring a specific expertise in the following fields:
CNS
Ophthalmology
Inflammation
Oncology
Metabolic diseases
Hormones
Osteoporosis
Virology
Dermatology
Urinary diseases
Antibiotics
Orphan diseases
Vaccines
Diagnostics
Metabolic Diseases
…and more
50 Due Diligence projects in big pharma and biotechs (6-8 a year)
In- or out-licensing
Co-development
Partnership
Commercial negotiations
II – SERVICES
Timely and cost effectively Project Management from Lead identification to Market according to regulatory requirements in the following fields:
• Drugs and medical devices
- NCE’s
- Biomolecules
- Vaccines
- Medical devices
- Diagnostic tools
• Animal health care
• Cosmetics
• Agrochemicals
• Chemicals
Partnership for the development of your products.
Research and documentation
• Scientific, technical and regulatory literature survey
• Scientific translation
• Implementation of thematic documents
• Actualisation of scientific documents
• Regulatory, scientific and technological vigilance
Medical, scientific, technical and scientific writing
Preparation of documents reflecting data accurately and consistently and adapted to target audience.
• Publications
• Book chapters
• Scientific brochures
• Expert reports
• Meeting minutes
• Congress abstracts and posters, slide presentations
• Subvention requests
• Business plans
• Advertising support
• Due Diligence dossiers
• Literature searches and reviews
Non-Clinical Study Monitoring
• CRO (Europe, North America, Asia) assessment, pre-selection, justified choice, audit and monitoring.
• Study plan implementation, study follow-up, audits.
• Report assessment, comments, correction and finalization.
Regulatory documentation
• IMPD, IB, IND, NDA, CTA, EC,
• CTD,
• Briefing Packages for regulatory authorities
• Expert reports and statements
• Replies to regulatory authorities
• REACH files.
Therapeutic and market fields
Expertise
Studies
• Consultancy on data requirements
• Organization and monitoring of experimental studies from study design and study plan to study report with strict respect of regulations and rules
• Study plan and study report review
Risk assessment
Dossiers and support
• Assessment with specific emphasis to
Pas de formation renseignée
