Scientific team
Medical and scientific expertise helps interpret complex product information.
Regulatory Affairs
Regulatory Clarity.
Responsible Progress.
Regulatory solutions built on scientific understanding, legal expertise and a commitment to responsible market access.
Clear requirements. Practical pathways. Responsible decisions.
Services / Overview
An integrated regulatory services portfolio
Marketing authorisation and product-licensing services, separate from clinical trial regulatory affairs.
MAH Services
Marketing Authorisation Holder (MAH) support.
Regulatory Gap Assessment
Application-readiness review and gap analysis.
GMP & Inspection Support
Good Manufacturing Practice (GMP) files, inspection applications and coordination.
Dossier Preparation & eCTD
Common Technical Document (CTD) preparation and electronic CTD (eCTD) submission.
Variations & Lifecycle
Type I/II variations, renewals and transfers.
Labelling & Product Information
Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) preparation and updates.
Pricing & Reimbursement
Pricing, reimbursement and pharmacoeconomics.
Scientific & Legal Coordination
Cross-functional input where relevant.
Not sure where to start?
Tell us about your product and we will point you to the right regulatory support.
Why Bpharma
Why Bpharma Regulatory Affairs?
Science, law and operations in closer dialogue.
Legal support
In-house legal expertise, including GDPR / KVKK perspective.
Connected ecosystem
Close links with Bpharma CRO, SMO and PV teams support coordination.
Accessible collaboration
Direct communication focused on the client’s real challenge.
Regional understanding
Knowledge of Türkiye and adjacent operational environments.
Flexible approach
Support tailored to the product, submission and engagement scope.
Bpharma divisions
One group. Four specialised divisions.
Let’s connect
Let’s Find the Right Regulatory Solution Together.
Every product and regulatory question is different. Tell us where you need support.
bpharmacro.com · info@bpharmacro.com