DEVELOPING INNOVATIVE STRATEGIES

ACHIEVING GROWTH

TWINZ PHARMACEUTICAL REGULATORY
AFFAIRS
Regulatory Affairs

 

COMPILATION OF NCE AND GENERIC CTD DOSSIERS FOR MEDICINES IN SOUTH AFRICA AND ENGLISH SPEAKING AFRICAN COUNTRIES

MEDICAL DEVICE APPLICATIONS

COMPLEMENTARY MEDICINE APPLICATIONS

COMPILATION OF:

- AMENDMENTS/VARIATIONS FOR SUBMISSION TO THE REGULATORY AUTHORITIES

- LICENSE APPLICATIONS FOR SAHPRA; DOH; SAPC

- SITE MASTER FILES

- STANDARD OPERATING PROCEDURES FOR REGULATORY DEPARTMENTS

- COMPILATION OF THE PROFESSIONAL INFORMATION AND PATIENT INFORMATION LEAFLET

COMPREHENSIVE TRAINING ON ZA CTD COMPILATION

INSPECTION READINESS

DUTIES OF THE RESPONSIBLE PHARMACIST & DEPUTY RESPONSIBLE PHARMACIST

PROFESSIONAL INFORMATION AND PATIENT INFORMATION LEAFLET TRAINING

REQUIREMENTS FOR SPECIFIC SADC ENGLISH SPEAKING AFRICAN COUNTRIES

SOUTH AFRICAN AMENDMENTS/ VARIATION REQUIREMENTS

VARIATIONS TO MARKETING AUTHORISATIONS IN THE EU

MEDICAL DEVICES: OVERVIEW OF REGULATORY AUTHORITY REQUIREMENTS

A DAY IN THE LIFE OF A REGULATORY AFFAIRS PHARMACIST OR OFFICER

ALL YOU NEED TO KNOW: PHARMACOVILIGANCE

MARKETING CODE

COMPANY SPECIFIC TRAINING & MORE

COMPLIANCE WITH LEGISLATIVE REQUIREMENTS TO HOLD APPLICANCY FOR PRODUCT DOSSIERS

Other services

 

PRINT AND SALE OF TABS/ DIVIDERS FOR BUSINESS OR PERSONAL NEEDS:

- CTD DOSSIERS

- FILING SYSTEMS

-AND MORE

TWINZ FOUNDATION FOR PHARMACEUTICAL SCIENCES
Training

 

ZIMBILI PHARMA CC
Applicant Holding

 

 

© 2019 Twinz Regulatory Affairs Pharmacist Consultants.