REGULATORY AFFAIRS


In the complex pharmaceutical industry, a combination of expertise, care and attention to detail are mandatory for any company that wants to successfully manoeuvre through the bureaucratic and regulatory maze.

COBEX Provides full-fledge Regulatory Affairs services to the Pharmaceutical and Lifesciences Companies for their hassle-free entry into USA, EU and Emerging Markets. We provide Regulatory Intelligence, guidance at all stages of product development, assistance in dossier compilation & filings, follow-up with Regulatory Authorities for approvals, response to queries (dossier related and GMP related, 483s and Warning Letters) and all support for product Life-cycle Management.

Our team of experts audit your facilities, do the gap analysis, suggest necessary remedial measures to ensure compliances with the regulatory requirements and be inspection ready. We do regulatory due diligence for our clients during license acquisition, license divestment, company acquisition and selecting new suppliers.

In the complex pharmaceutical industry, a combination of expertise, care and attention to detail are mandatory for any company that wants to successfully manoeuvre through the bureaucratic and regulatory maze. That’s where COBEX Scientific & Regulatory Affairs team comes in. From the beginning of R&D, through analytical development, to pre- and post-approval regulatory submissions, our team members can guide your project to a successful outcome.

COBEX clients receive all of the latest technical information needed. If you are a manufacturer, you can have confidence that our team is fully versed in the latest FDA and US DEA regulations and guidelines. It’s why we can provide you with keen insight about:


  • Drug Master File reviews
  • API imports
  • Facility inspections & Audit
  • Establishment registrations
  • Drug listings
  • IP Audit
  • IP Policy Development and renewal
  • Patent
  • Copyright
  • Trademark
  • Industrial Design
  • Geographical Indication

Other Services -


  1. WHO-GMP Certification - We provide service as pre-inspection and regulatory procedure for WHO.
  2. GMP plant setup and certification - We provide technical guidance to develop a GMP plant.
  3. Dossier Preparation and Submission - We provide assistance for Dossier preparation for new drug as well as for generics, compilation in CTD, ACTD, eCTD format, submission and answers to queries.
  4. DMF filling (USDMF, ASMF, JDMF) - We provide assistance for drug master file compilation in CTD format and submission to different countries as per their regulatory requirements.
  5. Post Approval Changes and Submission - We provide assistance to any submission related to post approval changes. Our technical team can guide you regarding different regulatory requirements for post approval submissions.
  6. Regulatory submission & follow-up - Dossier review & preparation, Response to USFDA queries, Dossier conversion to eCTD, ANDA preparation, Follow-up with USFD, DMF preparation & submission.
  7. Manufacturing Licensing (for Drugs or Cosmetics) - We provide assistance to get manufacturing license over all states of India for drugs as well as for cosmetics.
  8. Loan Licensing (for Drugs or Cosmetics) - We assist for Loan License Manufacturing for drugs as well as for cosmetics.
  9. COPP (Certificate of Pharmaceutical Product) - Certificate of Pharmaceutical Product required in case of export to specific countries, we provide assistance for that.
  10. BE NOC-We assist to get BE NOC for generic products. (Accordance to schedule-Y) - Import Registration & Licensing. We provide all regulatory assistance for import of pharmaceuticals in terms of premises registration, product registration and import license for fresh application as well as for re-application.
  11. Product and Premise Registration in Different Countries - For export to the different countries Product and Premise registration is required as per their regulatory authority, we have collaboration in different countries and can provide assistance
  12. Test License - We assist to get Test License for the import of small quantities of drugs for the purposes of examination testing or analysis.
  13. Export NOC - For Exporting pharmaceuticals outside the India, we assist to get Export NOC from CDSCO.
  14. Dual Use NOC - For import of items (Pharmaceuticals) having dual use or application and when their use as a drug is not intended. A NOC is required from zonal office of CDSCO we can assist you for this.
  15. Form 29 - We assist to get Form 29, a license to manufacture drugs for the purpose of examination testing and analysis.
  16. Pollution Control Board Clearance - We provide assistance to get clearance from State Pollution Control Board that is mandatory to get manufacturing license.
  17. Embassy Attestation - We provide assistance for document attestation from Embassies.
  18. Quality Documents - Good Documentation Practice -We provide assistance for Good Documentation Practice- draft quality documents as per regulatory compliance.
  19. Regulatory Plant Approval - We provide regulatory as well as technical assistance to get Plant approval from USFDA, MHRA and EMEA.



OUR MISSION

TO PROVIDE END TO END PHRAMA LIFE CYCLE SOLUTIONS AND HELP PHARMA SECTOR TO PRODUCE INNOVATIVE &
QUALITY DRUGS & MEDICINES AT LOW COST FOR THE WELLBEING OF PEOPLE



OUR VISION

TO BECOME THE CHOICEST & PREFFERED WORLD
CLASS PARTNERS AND ASSOCIATES TO FASCILITATE DRUG DISCOVERY & MANUFACTURING