Global Regulatory Affairs professional with expertise in CMC, Quality and Compliance. Supporting successful product registrations and lifecycle management across Europe, APAC, LATAM, and the United States.
Global Regulatory Affairs & CMC Expertise
Expertise in CMC and Lifecycle Management
Reliable Expertise for Successful Regulatory Approvals
I offer extensive expertise in Regulatory Affairs and CMC, with a focus on strategic planning and the implementation of variations to support sustainable product success.
15+
Years of experience in a strict regulated pharmaceutical environment.
100+
Successful variation approvals
25+
Product registrations
Strategic Submission Planning
Developing and executing regulatory strategies that support efficient submission, approvals and product lifecycle success.
CMC Expertise
Strong expertise in Chemistry, Manufacturing & Controls, ensuring product quality, compliances, and regulatory readiness.
Lifecycle Management
Managing regulatory activities throughout the product lifecycle, from initial approval to global variations and renewals.
Compliance & Regulatory Excellence
Ensuring compliance with international regulatory requirements while supporting sustainable business growth and patient access.
01
Regulatory Procedures
- Centralised Procedure
- Decentralised Procedure
- Mutual Recognition Procedure
- National Procedure
- FDA
- PIP-Waivers
- Scientific advices
- LIne extensions
02
Dosage Forms
- Sterile Injections
- Solid Oral Dosage Forms (Tablets / Capsules)
- Oral Solutions (Powder to suspension (Reconstitution); Powder to silution; syrup)
- Ointments
- Combination product
03
Therapeutic Areas
- Pain Management
- Neurology
- Oncology
- Cardiology
- Veterinary Medicinal Products
- Nutritional Products & Supplements
04
Dossier Types
- eCTD
- NeeS
- CTD
- Normative Document (ND)
Kontakt aufnehmen
Telefon: +49 (0) 163 336 1420
E-Mail: franka.juergens@cmcexperten.com
Adresse: Mannheim, Germany