Drugs

The regulation of Drugs in India, with respect to manufacturing and importing of drugs is primarily governed by the Drugs and Cosmetic Act and Rules ,New Drug and Clinical Trials Rules 2019 and various other regulations that are issued by the Government from time to time. These regulations are implemented in India by a 3 tier system, i.e., the Central Drug Standard and Control Organisation(CDSCO), the Zonal offices of CDSCO and the State FDA. 
We, at CoreLEX, help the manufacturers and importers in navigating these regulations at various levels by formulating watertight strategies and infallible dossiers,  so that our clients get their approvals in a time bound manner.
At CoreLEX, we guide our clients throughout the various stages of drug approval, constantly monitoring and advising our clients, on  dossier preparation to clinical trials, SEC meetings to  Medical writing, market research to legal documentation, among other services.
CoreLEX, is a one stop firm for all your regulatory needs.

We provide the following services to manufacturers and importers – 

To Manufacturers-

CoreLEX provides assistance to manufacturers in gaining necessary manufacturing license for the following - 

1.    Fixed Dose Combination (FDC)
2.    Investigational New Drugs (IND)
3.    New Drugs (ND)
4.    Subsequent New drugs (SND)

We also provide for other related services such as – 

1.    BE(Bioequivalence) NOC for Export/Export and Special Code NOC/Neutral Code NOC
2.    BE(Bioequivalence) Studies
3.    Toxicity Studie
4.    Clinical Trials
5.    SEC(Subject Expert Committee) Meetings
6.    Medical Writing
7.    Dual NOC

8.    Ethics Committee Registration

Other ancillary services – 

1.    Test License in Form 11
2.    Form 29 License/CT 11/CT14/CT15
3.    FSC (Free Sale Certificate)
4.    Retail/Wholesale License

To Importers – 

CoreLEX provides adept assistance to importers and other businesses in gaining necessary approvals and certifications with respect to following – 

1.    Import License
2.    Test License 
3.    Rule 37 License
4.    Shelf Life Extension 

CoreLEX Lex also provides for assistance for the following ancillary services  - 

1.    Authorised Agent Support
2.    Market Authorisation
3.    Registration Certificate 
4.    Re-Registration