Project Management – Development teams
DGr Pharma’s Project Management group offers you a wide range of services, from coordinating an individual trial up to the coordination of your entire development program.
Examples of what we can do:
- Design of a drug development plan according to clearly defined preset goals
- Core expertises: general drug development, pharmaco- and toxicokinetics, CMC and regulatory affairs
- Continuous automated monitoring of project deliverables (performance, timelines, costs), critical path identification and scenario building
- Management of CROs – from price & slot negotiations to final report.
DGr Pharma’s Non-Clinical Department can assist you with the operational aspects of your project and help you to define the non-clinical development program for your small molecules or biologics. If you wish, our consultants can participate in multidisciplinary project teams as non-clinical experts. Our Non-Clinical Department has extensive experience in the fields of toxicology (single dose, repeated dose, genetic toxicology and reproductive toxicology), safety pharmacology, pharmacokinetics and metabolism.
Clinical development – consultancy
DGr Pharma’s Clinical Department can assist you with the operational aspects of your project and help you to define your clinical development strategy, including the design of your studies. Outsourcing the conduct of your entire development program to DGr Pharma is also one of the options. Depending on the stage of your project and your specific needs, our clinical experts, pharmacokineticists and medical writers can contribute to your project and participate in the drug development team.
Pharmacokinetics – Data analysis
DGr Pharma has a strong history of analyzing drug concentration-time data that derive from all stages of drug development i.e. toxicokinetic studies, first-dose-in-man studies, bioequivalence studies (including bioequivalence statistics), Phase II/III, special populations etc.
- Fully trained Data Analysts perform the analysis under supervision of a senior pharmacokineticist
- In-house validated Phoenix WinNonlin and SAS routines are used for the calculations of the pharmacokinetic parameters (e.g. Cmax, AUC, half-life) and reporting of the data in tables and graphs
- High quality GCP, GLP (including multi-site studies according to OECD guidelines) or GLP based procedures will be followed, depending on the request of the sponsor, refer to our endorsement of GLP Compliance
Chemistry, Manufacturing & Control (CMC)
DGr Pharma’s department of Chemistry, Manufacturing & Control (CMC) can assist you with an extensive range of activities related to the development of small molecules, biologicals and generics/biosimilars.
We can actively participate in your project at various development stages:
- Support of business strategies by writing of Target Product Profiles and Drug Development Plans, performance of Due Diligences and GAP Analysis and the preparation of Data Rooms.
- Development of Drug Substance and Drug Product (formulation) from initial laboratory scale up to the final c-GMP commercial scale focusing on the timely manufacturing of non-clinical and clinical trial material.
- Selection of Contract Development and Manufacturing Organizations (CDMO) using our worldwide CDMO database.
- Project management assuring the realization of project deliverables according to timelines and budget.
- Development, qualification and validation of analytical methods.
- Writing and reviewing of study protocols and reports, IMPD/IND, CTD module 3, etc.
- Performance of GMP audits, GMP readiness checks and compliance checks.
DGr Pharma provides expert opinions on regulatory-related questions and procedures and liaises to regulatory authorities.
What we can offer for your chemically synthesized products, biotechnological products and biologicals:
- Consultancy by experienced people on regulatory issues within your drug development process
- Preparation of CTD Module 1 and 2
- Submission of the dossier and contacts with Regulatory Agencies
- Assistance in and preparation of scientific advice/IND submissions or meetings
The Quality Assurance Unit (QUA) at DGr Pharma is responsible for the Quality Management System, which is based on the OECD Guidelines of Good Laboratory Practice (GLP) and ICH E6(R2) (GCP).
The objectives of QAU are:
- Ensure a constant quality of PK/TK analysis and reporting
- Study-related GLP audits are performed during all critical study phases
- Facilities and systems are audited according to a predefined QA audit program
- Audits of validated computerized systems are performed on a regular basis
- On request of the Sponsor audits can be performed on different phases of non-GLP/GCP studies
- All procedures are laid down in SOPs, which are reviewed by the QAU
- Assist clients on questions regarding quality and quality systems
- Implementation of (parts of) QMS systems e.g. archiving; CSV, document management, CAPA management
- Vendor/third party audits on behalf of sponsors
- GLP Study audits
- GxP facility audits
- GCP system audits
- QC activities
- Audit/inspections readiness
- GxP Training
IT and Data Storage
Integrity and security of records and data is essential throughout the product life cycle of any pharmaceutical company from R&D up to marketing. As a startup company in the area of life sciences, your main focus should be on the development of your product. With DGr Pharma as your IT partner, you can rely on our expertise to implement and maintain your IT infrastructure. Our team of senior technical engineers have a strong background of working in IT-related environments in the pharmaceutical industry and will ensure that your data will be available and accessible anytime, anywhere without compromising security or data integrity.
Contact us for more information
4731 RA Oudenbosch
Tel: +31 165 74 20 30