Regulatory & Legal Consultancy

FSSAI Services

FSSAI (The Food Safety and Standards Authority of India) has established under the Food Safety and Standards Act, 2006 as a statutory body for establishing authentic scientifically proven standards food articles. The agency also regulates manufacturing, processing, distribution, sale and import of food articles so that safety for human consumption is guaranteed. Our expert team provides advises for filing food product approval, food licensing & registration and food import license.

DCGI Services

DCGI (Drug Controller General of India ) has set definite norms to allow the Marketing of products & also issues various certifications for the smooth functioning as per the rules.

We offer specialized advisories with the following services:

• Import Registration of Drugs/ APIs/ Cosmetics/ Medical Device
• NOC of Bioequivalence Study/ Shelf life/Special Neutral Code
• NOC of Clinical Trial Study
• Import License or Form-10
• Import Test License or Form-12tion
• PSUR Submission

NPPA services

NPPA (National Pharmaceutical Pricing Authority) has the responsibility to fix & revise the price of controlled bulk drugs & formulations. The department is responsible for the recovery of overcharged amount by the manufacturers or Marketing companies for the controlled drugs & medical devices. NPPA also issues show cause notices & Legal notices to the violators.

We provide the following NPPA advisories to the companies:

• Advise on Product Approval From NPPA For Price Fixation
• Advise on Price Review Application Considered by NPPA
• Advise Against Overcharging Order/Penalty Imposed by NPPA
• Advise on Submission & Follow Ups

Pharmacovigilance

Drug development takes billions of dollars to go through different stages till the safety is determined. It then requires to have a systematic process to establish the safe and sound reach of the drug for the humanity. A proper manufacturing process & efficient storage is required as per the norms set in. In spite of the huge expenses incurred in the development & launch phases the companies are worried about the regulatory rules & regulations which are subject to change from time to time. This further has cost the companies huge punitive amounts to clear the processes.

Thus the pharmaceutical industry has opted for active& updated Pharmacovigilance services & we are proud to offer the following services in this context.

• Pharmacovigilance System Master File (PSMF)
• Risk Management Plan (RMP)
• Periodic Safety Update Report (PSUR)
• Adverse Drug Reaction Monitoring (ADRM)
• Customised Scientific Manuscript Writing
• Individual Case Safety Report Processing

Dossier Documentation

Analytical documentation is necessary for export Registration & it requires expert team to verify the same so that the timely action is ensured & also the extra expenditure is saved.

We offer the following analytical Services:

• AMV of Assay
• AMV of Impurities
• AMV of Residual Solvent
• Process Validation Report
• Related Substance Analysis
• Comparative Dissolution Profile
• Method of Analysis
• Stability / Photo Study

Export Registration

Those who want to enter exports, we offer the following services to make their entry smooth:

• Guidance on product selection for marketing
• Dossier compilation as per regulatory guideline
• Registration handling in a professional way
• Drug Master File on CTD Format
• Consultation in Developing Export Division
• We will provide visa and export market visits

Legal Advisory

Legal Associates play an important role because the misuse of drugs can result in hazardous outcomes.

We offer expert Legal advice to the Pharma companies in the following:

• NSQ
• Drug Criminal Cases
• Drug Prosecution
• Trade Mark and Patent Dispute
• NPPA Litigation
• Public Interest Litigation
• Licensing / Delicensing
• Trade Mark Registration
• CDSCO Litigation
• FSSAI Litigation