Drug Development Consulting

Pharma IT has an experienced team of Drug Development Consultants ready to assist you with services in all the phases from early phase clinical development until late phase; and well into the post-marketing phase.

We currently cover the following specialty areas with our own consultants

  • Chemistry, Manufacturing and Controls (CMC)
  • Clinical Trial & Operation
  • Scientific & Medical Writing
  • Clinical Data Management
  • Drug Safety & Pharmacovigilance

Where as the following areas are covered by partners and via our extensive freelance consultant database:

  • Biostatistics
  • Regulatory Affairs

If you need support don’t hesitate to contact us.

Meet the Drug Development Consulting team:

Senior Pharma Consultant
Birthe Moesgaard

Experience with quality demands for active pharmaceutical ingredients and medicine products for the European market, according to The European Pharmacopoeia as well as to the ICH guidelines.

Experience with quality demands according to EMA guidelines, quality demands for the documentation submitted to the Danish Medicines Agency for applications for variations to existing Marketing Authorisations as well as for applications regarding new Marketing Authorisations.

Experience with development, optimisation and validation of analytical methods for implementation in European Pharmacopoeia monographs, assessment of the practical applicability as well as the documentation for analytical methods including the validation hereof, for active pharmaceutical ingredients and medicine products for the Danish Market.

Experience with assessment of applications for variations to Marketing Authorisations for the Danish and European market.

Mass Spectroscopy Coupled to Separation Techniques in Bioanalytical Chemistry, Regulatory Life Cycle Management, Transferring HPLC methods to UHPLC, NMR Techniques in Drug Research, Advanced HPLC Method Development, LC Troubleshooting, Validation of Analytical Methods, Course in Industrial Drug Development, Sample Preparation and Separation Techniques in Bio-Analytical Chemistry, Author of 16 peer reviewed scientific papers. Numerous presentations at OMCL (Official Medicines Control Laboratories) meetings in countries around Europe, and at Expert group meetings at EDQM (European Directory for the Quality of Medicines & HealthCare) in Strasbourg.
Senior Pharma Consultant
Maria Høyer Engelhardt

Senior Pharma Consultant Maria Høyer Engelhardt holds more than 10 years of experience working in the pharmaceutical industry, working with quality, validation and processes, primarily within Quality Control. She has extensive experience within Quality Control, in particular with documentation, verification and validation of methods, set up and documentation of new processes, SOP writing and LEAN. Furthermore, she has good knowledge of QMS systems and the document structure.

Experience with development and validation of microbiological methods and  methods for raw materials.

Various cGMP courses , LEAN, Project Management
Clinical Project and Trial Manager, Senior Pharma Consultant
Birgitte Sloth

Experienced Clinical Scientist, Trial and Project Manager with more than 15 years of experience with scientific, operational and strategic parts of project and trial management, functioning as Global Study Lead and Clinical Project Scientist. Extensive experience with vendor and stakeholder management, protocol authoring, management of clinical trial teams, and clinical project management within early phase clinical development including phase I-II and phase III in a rare disease indication.

Academic background in metabolic disease area and working experience in obesity, diabetes, cardiovascular, immunology, dermatology, respiratory, musculoskeletal and neuroscience disease areas.

Experience within translational medicine, pediatric investigational plans, NDA submission.

Clinical Project and Trial Manager, Pharma Consultant
Berit Grevstad

Experienced international clinical trial manager and site manager from Clinical Research Organizations and Academia.  Experienced in start-up of multinational Phase I – IV clinical trials, including development of trial related documents such as trial protocols, risk management plans, monitoring plans and eCRFs.

Academic background as project manager in infectious disease areas (HIV, Malaria, Ebola) and working experience in infectious diseases, vaccine development, immunology, hematology, oncology, diabetes, cardiovascular, respiratory, and neuroscience disease areas.

Data Management Consultant
Frank Andreasen

Senior Data Manager with more than 17 years of experience within the pharmaceutical industry.  Clinical Data Manager experience encompasses; CRF/eCRF design, database design, data entry, data validation, query handling, protocol deviations, SAE reconciliation, quality control, user acceptance test, system validation, standard procedures, laboratory data, data import/export, coding procedures, CDISC SDTM standards, risk-based monitoring and data management oversight.

Director of Clinical Trial & Operations, Clinical Project and Trial Manager
Maria Wriedt Jakobsen

Senior Clinical Trial Manager and Project Manager with more than 13 years operational and strategic experience with planning, overseeing and managing international clinical trials. Experience with authoring clinical trial protocols, oversight plans, risk management plans including risk-based monitoring, communication plans and executing investigator meetings, monitor meetings and internal company clinical trial meetings. As well as very experienced with vendor and stakeholder management.

Academic background as Cand. Pharm and working experience in diabetes, hematology, dermatology, neurology, oncology as well as orphan diseases.

GCP, ICH GCP E6 R2, GCP monitoring, Project Management, Change Management, Outsoucing of clinical trials, Observational studies, RA M8: Clinical Development and Documentation
Director of Chemistry, Manufacuturing and Control (CMC)
Torben Elhauge

Holds more than 25 years’ experience from the Pharmaceutical industry within the CMC area.

Experience working with both active pharmaceutical ingredients and medicine products for the European and American market, according to guidelines, ICH guidelines and the Pharmacopoeias (EP, PB, DLS and USP).

Broad experience within validation of analytical methods according to ICH Q2 (R1) and verification of monographs. Have been a tutor both at Pharmacon and at the MIND education under the university, lecturing in QC and analytical validation.

Experience working with registration files for the European and the American market both writing sections of the file and as an assessor within the Danish Medicines agency. Have been a part of the planning and execution of an advisory committee meeting as a part of the FDA registration process.

Experience from small development companies working in project teams and from quality control in larger setups. Always under GMP. Have also functioned as leader of an analytical development laboratory for several years.

Experienced in working with, CRO’s and Tech Tranfer.

Have held inspections both as an analytical expert within the Danish medicines agency and as a company representative. Have also functioned as an auditor for internal and external audits.

Torben holds a master’s degree in chemical engineering.

GMP, Quyality guidelines, Quality systems, HPLC, Dissolution, Analytical validation, Analytical development, Inspections, Audit,
Pharmacovigilance Consultant, Quality & Compliance Consultant
Maria Skou Andersen

Cand.pharm with five years of pharmacovigilance experience including strong knowledge of MedDRA coding. Successful completion of EMA’s XEVMPD knowledge evaluation. Capable of providing guidance and training to new EVWEB users for them to comply with the reporting guidelines. Capable of creating and updating XEVMPD records. Experienced with databases such as Argus, Empirica and QlikView. Currently studying Master of Pharmacovigilance at the University of Hertfordshire, UK. EDMS system expert with advanced Veeva system administrator certification and experience with Veeva implementation. Experienced with compliance tasks such as system validation within the drug safety area.

Certified Veeva Vault Administrator, Veeva
Medical Writer Consultant
Kaushik Sengupta

Senior Medical Writing Consultant with over 8 years of experience from the pharmaceutical industry as a Senior/Expert Medical Writer. Has prepared numerous high-quality regulatory and research documents for leading global pharmaceutical companies. Typically, these documents have been based on Phase I–IV studies from most major therapeutic areas. Holds a Master in Dentistry from Canada and has pursued a PhD in epidemiology from Copenhagen University.

Pharmacovigilance Consultant
Mie Altermann Sørensen

Pharmacovigilance professional with 6 years of experience from the pharmaceutical industry. Experience from working in both headquarter and affiliate. Includes: Signal detection, literature monitoring, pharmacovigilance training, individual case safety report processing, including coding and narrative writing, scientific evaluation and reporting. Medical information activities; writing medical responses to health care professionals, direct costumer contact. Studying Master of Medicines Regulatory Affairs. 

Data Management Consultant
Jens Sørensen

Clinical Data Manager with pharmacy background and 18 years of experience from the pharmaceutical industry. Experience as both insourced and outsourced consultant with all aspects of clinical data management including; CRF/eCRF design, database design, data entry, data validation, query handling, protocol deviations, SAE reconciliation, quality control, data import/export, SAS and SQL programming, data migration, CDISC SDTM standards, MedDRA/WHODrug coding, risk based monitoring and data management oversight.

Pharmacovigilance Consultant
Louise Søgaard Nielsen

10 years of experience as a pharmacovigilance professional. Experience with all aspects of pharmacovigilance including; ICSR case processing and reporting, Signal Detection, PSUR and DSUR writing and submission; Risk Management Plans and maintaining and building quality management systemst a larger pharmaceutical company in the Copenhagen area.

Data Management Consultant
Faiyaz Hussein

Is a Data Manager with 15 years of Clinical Research experience with respect to Project Management, Data management, eCRF and database designing, validation of IT systems, integration testing, reporting on varied EDC systems, electronic patient reported outcomes ePRO, edevices in diabetes care (Insulin pumps, CGM) and submission to Health Authorities with major pharmaceuticals.

21 CFR Part 11, GCP, Six Sigma Green, BASE SAS, Inform, Medidata Rave, Clintrial 4.4 EDC’s and OC/RDC
Pharmacovigilance Consultant
Kristine Kornøe

Experienced in clinical and postmarketing safety after working 6 years as a Drug Safety Advisor in a large danish HQ. Experience include: Signal Detection, PSUR/PBRER and DSUR writing and submission; Risk Management Plans; maintaining and building quality management systems; pharmacovigilance training, E2B reporting, ICSR case processing and reporting.

Data Management Consultant
Evangelos Kapris

Experienced Clinical Data Manager with experience within: CRF/eCRF design, database design, data entry, data validation, query handling, protocol deviations, SAE reconciliation, quality control, data import/export, SQL programming, data migration, CDISC SDTM standards, MedDRA/WHODrug coding, risk-based monitoring and data management oversight.

M.Sc. Data Mining
Partner, Drug Development Consulting
Ea Marie Holst
+ 45 30 22 23 21

Pharmacovigilance professional with more than 14 years of experience working in both headquarters and affiliates within; Signal Detection, Risk Management Plans, PSUR/PBRER and DSUR writing; maintaining and building quality management systems; pharmacovigilance training, E2B reporting and testing, handling of individual cases. Trained user of several adverse event databases.