Team Regulatory

Filing of NDA / ANDAs in US and ASMFs in EU
Preparation of Generic Applications such as Paragraph II, III and IV
Post approval maintenance and submissions of PAS, CBE 30/CBE, Annual Reports in US and EU
Help with creation of customized FDA regulatory/development strategies
Help with writing all submission documents
Design Final Printed Labeling and Container Lab
Help with responding to FDA questions during the approval process
Help with eCTD process and provide eCTD Preparation Services
Help with filling annual reports, adverse reactions, and ongoing CMC updates
Manage Good Manufacturing Practice (GMP) and clinical site audits.
Act as a U.S. Agent for non U.S. companies
Provide Pharmacovigilance Services including PADER and ICSR Submissions

Preparing drug applications, amendments, annual reports, PADER submissions etc in eCTD format using industries leading eCTD preparation software
Validate the submissions using industries best validator which is used by FDA like agencies across the globe including EMEA
- Note: Our Parent organization is professional partners and official resellers of EXTEDO’s eCTDmanager for eCTD Preparation for USA and Asia. eCTDmanager is being used by agencies such as FDA in 35 countries across the globe including EMEA for reviewing and validating the submissions. Provide first level support for eCTDmanager software in NA and ASIA markets
SPL Preparation for Establishment Registrations, Labeler Code Requests, Drug Listings, GDUFA Self ID Submissions etc.
DUNS and establishment registration, self identification for all sites for drugs

Represent our client organization for establishment registration and Product specific communications with FDA as US Agent
Receive and respond to FDA communication over the phone and/or email or in person meetings if needed, representing the business from USA

Team Regulatory and PMCS (Pharmaceutical Management Consulting Services) collectively offers comprehensive support services to the pharmaceutical industries. Big challenges for pharmaceuticals in developing countries, are knowledge, skill and competency development of professionals willing to become global or international in operations and products.

PMCS primarily offers, training to the industry professionals from:

Regulatory
Production
Product Development (R&D)
QA
Engineering on cGMP
ICH Guidelines
WHO GMP

Important topics on:

U.S. FDA Regulatory Compliance
Generic Drug Approvals
ANDA Submission Requirements
Introduction to Electronic Submissions
cGMP
QbD
PAT
QRM
Change management
CAPA
Deviation Management
Vendor Qualification
Process and Cleaning Validation with other specific topics.

Management Consulting

Team Regulatory and PMCS (Pharmaceutical Management Consulting Services) provides other key Services to the Pharmaceuticals.

Some of them are:

Pellets and MUPS development support
Development of MR products
Development of IR products
Audit and Gap analysis
Assist documentation support, for BMR, BPR, AR
Generation and review of SOP
VMP
SMF
Analytical Method Development
Stability studies

There are other support services, demanded by the industries, can also be provided.

GMP/GxP Validations

Laboratory Systems (HPLC, FT/IR etc.) Validations
Prepartion of Validation Protocols
Execution of Validation Protocols
SOPs Preparation
SOPs Training

Systems Validation

Computer Systems Validation (CSV)
Custom Business Applications and Software Validations
Validation Protocols Preparation
Execution of Validation Protocols
SOPs Preparation
SOPs Training

+1-609-843-0303

+880-17307-18327