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 Trilogy Writing & Consulting GmbH |
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Trilogy Writing & Consulting GmbH
Falkensteiner Str 77
60322 Frankfurt
Germany
Email: writers@trilogywriting.com
Web: www.trilogywriting.com
Title: Business Development Manager
First Name: Evija
Last Name: Kümmel
Phone: +49(0) 69 138 2528-22
Fax: +49(0) 69 138 2528-55
Skills And Services Offered:
Trilogy is focused entirely on medical writing and medical writing training, offering the full range of regulatory clinical documentation across all therapeutic areas.
Trilogy provides “best of breed” Medical Writing with an in-depth understanding of regulatory documentation and the expertise necessary to crystallize the ultimate messages. This ensures a quality that minimizes the time for authority review and approval.
We pride ourselves on our “dedicated team” approach when developing documents, which greatly reduces the time needed for production and ensures much greater levels of continuity throughout an entire development programme. Concretely, we offer a very high speed of turn-around, which may be crucial to reducing the time to market.
Trilogy Portfolio overview of Clinical Documentation
| ASR |
Annual Safety Report |
| CDP |
Clinical Development Plan |
| CSP |
Clinical Study Protocol |
| CSR |
Clinical Study Report |
| CTD |
Common Technical Document |
| CTR |
Clinical Trial Report |
| IB |
Investigator‘s Brochure |
| ICF |
Informed Consent Form |
| IMPD |
Investigational Medicinal Product Dossier |
| IND |
Investigational New Drug |
| PI |
Product Information |
| PIP |
Paediatric Investigation Plan |
| PSUR |
Periodic Safety Update Report |
| RMP |
Risk Management Plan |
| SmPC |
Summary of Product Characteristics |
| USPI |
United States Prescribing Information |
Expertise:
We have written documents in the following Therapeutic Areas:
| Anti-infectives |
Oncology |
| Behavioural health |
Paediatrics |
| Blood products/haematology |
Respiratory |
| Cardiology |
Rheumatology |
| Dermatology |
Skeletal disease |
| Endocrinology/metabolism |
Urology |
| Immunology |
Vaccines |
| Neurology/ Central Nervous System |
Women‘s Health/ Gynaecology |
| Ophthalmology |
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..and in the following Development Areas:
| Phase 1, 2, 3 and 4 |
Pharmacodynamics (PD) |
| All Types of Submissions |
Biotech |
| Responses to Authorities |
Biologics |
| Agency Hearings / Meetings |
Devices |
| Pharmacokinetics (PK) |
Orphan Drugs |
Other Information:
Please, visit our website for additional information, including three short videos by the founding partners, which give an idea of the style and philosophy of Trilogy.
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