WE MAINLY PROVIDE SERVICES UNDER BROAD CATEGORIES
Pharma, Biotech, Medical Devices, Neutraceuticals, Herbals registrationsand getting marketing approvals across the Globe
GxP compliance services which includes [GMP, GLP, GCP, GDP, Due diligence, Validations, CSV, Data integrity etc.
Audits & PAI as per country-specific requirements
Regulatory Compilation of all modules CTD-M1, M2, M3, M4, M5 and Global Submissions (pCTD, eCTD, ACTD, NEES formats) and Technical , CMC writings, 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.
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)
Support industry to harmonize countries wise electronic submissions format, Multi stage review by using effective quality review checklist Structured Product Labeling (SPL); 1) Expertise in conversion of FDA compliant & validated SPL files (XML) 2) NDC Labeler Code / Establishment Registration / GDUFA Identification 3) Drug Labeling (Prescription, OTC and Compounded) 4) Life-cycle management of SPL (version and set id management) 5) SPL validation as per FDA compliant and specification (zero error)
MAA CTD for Europe Submission, South Africa-CTD, Australia-CTD, Kenya & Uganda CTD
ACTD ie. ASEAN CTD (Malaysia, Thailand, Philippines, Singapore, Myanmar, Cambodia, Vietnam, Indonesia, Brunei, Laos) Preparation and submission of ANVISA GMP Inspection documents, ANVISA CTD dossiers, Validation package.
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
Dossier writing from Module 1 to Module 5 for generic and new drug application [IND, NDA, ANDA, BLA]
Quality Module 3- CMC and Scientific Writing
Critical Review of Dossier and Preparation of GAP Analysis Report,
Existing dossier suitability to new market (Gap analysis and solution)
US-DMF [Type II Drug Master File review and writing in ICH-M4Q format], Active Substance Master File (ASMF)-EU, KDMF (Korean), DMF Type III & Type IV [ Excipients & Packaging materials].
CEP & CoS (Certificate of Suitability to the monographs of European Pharmacopoeia) submission to EDQM
APIMF (WHO), MF (PMDA, Japan) and emerging markets DMF
Product Life cycle Management i.e. Product variation / amendment application - Defining the type of variation (Type I or Type II for EU, PAS, CBE 30 or APR for USA), reviewing technical data, preparation of application and submission to health authority
Query response - Preparation of query response based on Health Authority’s query and timely submission to our client / authority
GMP , GLP, GCP Audits and Compliance, Due Diligence of third parties/vendors
Validations Services ( i.e. Analytical Method Validation, Process Validation, Computer System Validation - CSV as per EU Annex-11, GAMP-5, 21 CFR parts11)
Validation & Qualification of Pharmaceutical Mfg Equipments & Laboratory Instruments [DQ, IQ, OQ, PQ] with complete validation documentation.
Regulatory Compliance Audits, and Mock Audits (PAI)
In House Training and Workshops into RA, QA, GMP, ICH, QbD, Clinical Research, PV, Patent, Validations and related areas, etc.. We can make TAILOR-MADE training programs as per your requirements.
Pharmacovigilance & Medical Writing services
Formulation Development(QbD) , Support for Clinical Trial, BE study and Toxicity Study and Technology and Site transfer etc
Support in Product Development and Technology Transfer, and support in BA/BE studies