Services

Services

Consultancy for registration of veterinary medicines, vaccines and biologicals

Regulatory science, boards, management, scientific writing


Questions? Contact me at info@centralvetpharma.com

European Medicines Agency 

Centralised procedure; application, responses, strategic options, precedence


Preparation for Oral Hearing for CVMP, training and guidance


Scientific advice requests for predictability of acceptance


Referrals; planning responses, scientific writing


Re-examination of Negative Opinion


List of Questions; writing responses, assess adequacy


EMA contacts, questions, product classification

New product development

Regulatory review of novel therapies or new concepts


Gap analysis of data for marketing authorisation applications


Product development plans (safety + efficacy); pharmaceuticals, biologicals, vaccines.


Novel therapies;

gene technology,

DNA-vaccines,

stem cell products


Review of clinical trial protocols, VICH GCP


Clarify MRL-status for active ingredients or excipients ('allowed substance') and your options

Regulatory science EU

Expert reports (DACS) for safety and efficacy of pharmaceuticals, biologicals, vaccines


SPC harmonisation


Limited Market – Minor Use Minor Species – classification, Reg. 2019/6 §4/ §23, guidelines for reduced data requirements


Regulatory classification of biologicals; immunological vs non-immunological


New veterinary medicines EU Regulation 2019/6, applicable from 28/1 2022

Board positions

Open for positions in Management board / Board of directors


Experience as CEO, stock market registration (IPO), management board sparring


Advisory board experience

Leading scientific groups

Chairing of scientific groups


Management of project groups


Progressing and participation in drafting groups

Scientific writing

Courses in regulatory science topics


Scientific writing, including articles for publication


Conference conclusions or minutes.