THE MODULAR FORMAT OF THE CTD -AN OPPORTUNITY
All departments of a pharmaceutical company can contribute to the efficient compilation of the dossier.
The guidelines provide clear advice on the content of each module.
Individual modules can be prepared as original documents by the appropriate R&D department. The Regulatory Affairs Department of the company needs to provide clear guidance on the requirements on content and format for each module. Company templates can be prepared for each module.
ABOUT US:
RAAJ GPRAC PVT. LTD, India incorporated in the year 2010 which is directly benefiting the society with well-planned welfare projects in Life Sciences; Pharma industries. The Management of RAAJ GPRAC, duly incorporated / registered under the relevant Act and based in Thane district.
RAAJ GPRAC was founded by Rajashri Survase Ojha in 2010 and have been successfully completed 10 years as a Global RA CONSULTANT, TRAINERS & AUDITORS. We offer services into Pharma, Biotech/Biosimilars, Medical Devices, Neutraceuticals, OTC, Foods, and Veterinary after having 27+ years of industrial experience from Sandoz, Ciba-Geigy, Local FDA, Glenmark, GSK-TCS, Novartis, Famycare, Pregna International, Cognizant, Spectrum Pharmatech, Synergy Pharma UAE etc, We do provide GMP, GLP, GCP , GDP & Regulatory services and Pharma TRAININGs across the world through CLASSROOM [CL] Training & DISTANCE learning [DL] education.
Mission of RAAJ GPRAC is to empower the employees productivity and skills development through relevant education/Skill development and market-focused livelihood programs. Education and knowledge is very important for a better life. So knowledge is the power and there is no bigger power than the knowledge of power itself. We conduct various Technical Sessions, Awareness Session and also Power pack sessions for employee productivity.
We are specialized into customized certified Skill Development Programs as per the need of the organization so that manpower will be readily available with the set skills.
Our courses are recognized by Government and NSDC accredited through LSSSDC[Life Science Sectors Skill Development Council]. Our institute is ISO 29990-2010 certified which provides all Advanced knowledge to Fresher’s skilling and Up-skilling for working professionals from Pharma, Biotech, industries and CRO, BPO, KPO etc to BOOST their career. All trained candidates get jobs very easily and prosper into their career very fast. We offer courses as CLASSROOM LEARNING (CL) on Sat/Sunday or through DISTANCE LEARNING (DL) programs. We have trained more than 9500 candidates till date on various subjects across the GLOBE.
The organization profile of RAAJ GPRAC PVT LTD is attached herewith for your ready reference and we can offer a wide range of diversified services as per customer specific requirements:
RAAJ GPRAC regulatory consulting and intelligence team is comprised of senior Regulatory & GMP experts with extensive experience(More than 25yrs) in product development, preparation of global registration strategies and successful registration of drug substance & drug products with different regulatory authorities worldwide. Our team helps in development of drug products as per global regulatory strategies that enable the most efficient registration pathway(s) and yield a high probability of approval success as per country-specific requirements.
We mainly provide services under broad categories;
Ø The portfolio has been developed specifically to help customers expedite the regulatory submission & APPROVAL process and speed time to reach out
GLOBAL market in DRUGS, DRUG PRODUCTS, MEDICAL DEVICES, BIOTECH/BIOSIMILARS, VETERINARY, FOODS & NEUTRACEUTICALS ETC..
Ø GxP compliance services which includes [GMP, GLP, GCP, GDP, Validations, CSV, Data integrity etc.
Ø Audits & PAI as per country-specific requirements. REMEDIATION & SOLUTIONS after 483's & Warning letters.
Ø Regulatory Compilation and Global Submissions (pCTD, eCTD, ACTD, NEES formats) and Technical , CMC, GMP Validation documentation support as per USFDA, EMA, TGA, MCC, UK-MHRA, SFDA, GCC, CFDA , RoW, Russia & CIS, Indian DCGI & CDSCO and other country-specific requirements.
Ø Structured Product Labeling (SPL) for US. Regulatory Operations; Support in submission management planning and publishing strategy, Assist in Document Level (DLP) and Submission Level Publishing (SLP)
Ø MAA CTD for Europe Submission, South Africa-CTD, Australia-CTD, Kenya & Uganda CTD
Ø ACTD ie. ASEAN CTD (Malaysia, Thailand, Philippines, Singapore, Myanmar, Cambodia, Vietnam, Indonesia, Brunei, Laos)
Ø Labeling Management - Preparation of draft Labels for Primary and Secondary Packaging Materials, Patient Information Leaflet &SPC. Side by Side comparison of Labels in reference to innovator
Ø Dossier writing from Module 1 to Module 5 for generic and new drug application [IND, NDA, ANDA, BLA, DMF, ASMF, CEP etc
CTD. eCTD, Nees, ACTD, MRF and RoW formats.
18 ноя 2019
