Regulatory Affairs

We offer complete Regulatory Affairs support to Pharmaceutical Clients and assist Clients in obtaining approval for drug product.

Generics:

Drug development services

• Guidance on drug development
• RLD Selection for drug development

Markets

Regulated, Semi regulated and Rest of the world markets (ROW)

CTD Dossier Preparation services

Regulated, Semi regulated and Rest of the world markets (ROW)

• CTD Dossier preparation (Module 1- Module 5) for all types of dosage forms
• Supplements (CBE 0, CBE 30, Annual Reports and PAS)/Variations (Type IAin,Type A, Type IB and Type II)
• Renewals
• PSUR/PBER
• Product Lifecycle Management
• Expert reports preparation (Module 2.4 & 2.5)

BA/BE Services

• Protocol development, review and approval of BA/BE protocol.
• BENOC & T License filing & approvals
• Study monitoring
• RLD selection for BE study
• Signal detection reports preparations

Procedure management services

• All type of EU Procedure(National/Centralized/MR/Decentralized)
• RMS and CMS selection

Product information package preparation services

• SPC, PIL, Labeling/Artwork Preparation
• National Translations
• Company Core Data Sheets (CCDS) preparation

eCTD Services

DMF Services

• Type II DMF compilation, preparation and review
• Response to queries
• Variations

General service

• Benefit/Risk assessment of a product
• RA department establishment/setup
• Elemental Risk Assessment Preparation

New Drugs:

New Drug development services

• Guidance on API drug development and Formulation drug development
• RLD Selection for drug development

Pre-IND services

• Advice on Pre IND activities
• Guidance on TPP (Target Product profile) preparation
• Medical rationale for 505 b2 process
• Investigator brochure preparation
• Pre-IND meeting briefing package preparation
• Meeting request preparation

IND Services

• IND/CTA Dossier preparation
• Clinical hold issues resolution

NDA services

• NDA dossier preparation (Module 1-Module 5)
• Response to Queries/Amendments
• Supplements/variations

Dossier Due diligence and Technology Transfer Activities

• Third party auditing in GMDP
• EU Inspection audit preparation and co-ordination
• QP/RP services
• GMDP training
• Project management (Eg: Data integrity, e-QMS roll out, CAPA remediation etc)