Greetings from ECS...!

We are a leading pharmaceutical consultancy for comprehensive technical services, by highly educated and well experienced professionals. Our Unique and Key (Quick) Services are:

1. Risk Based Investigation (RBI) Audit and Compliance: QC & QA Doc., & QMS upgrades.

Q.C. - Analytical Method Validation Protocol - Product wise - STP, SPEC & AMV. Equipment Qualification - I.Q, O.Q, P.Q. of HPLC, IR, UV, Dissolution Apparatus, GC, Stability Study Protocol Product wise.

Q.A. :- Process Validation Protocol - Product wise - MFR, BMR & BPR. Cleaning Validation Protocol, Clean & Dirty Hold Time Study Protocols, Water System Validation, AHU Validation (I.Q, O.Q, P.Q) Protocols. Media Fill Validation Protocol, Quality Material Validation, Master Plan, Site Master File as per Revised Schedule M.

Qualification Documents of Production Equipment, (Example: Compression Machine, Filling Machine, Blister Machine, etc...) Department wise SOP & Log Book - Department wise for HR, Production, QA, Store, QC (Chemical & Micro.) and Maintenance (Utilities, Air System & Water System)

2. Facility Qualification and Validation (FQV) & Computer System Validation (CSV)

3. All India (any state) Loan Lic. Approval. Techno Transfer Documents with 6 months stability report for product endorsement. DCGI new molecule product approval (within 4 months*) from Delhi. State Drugs Products Approval.

Example:- A) Linagliptin 5mg + Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10mg Film Coated Tablets

B) Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin + Sitagliptin Phosphate monohydrate IP eq. to Sitagliptin + Metformin Hydrochloride IP (5mg + 50mg + 500mg & 5mg + 50mg + 1000mg) film coated tablets

4. WHO-GMP Documentation: Preparation as well as review, Inspection Readiness:- WHOPQ, PERU, PICS, EU, MHRA, TGA, etc.

5. Greenfield and Brownfield Projects: From layout preparation to certification (26 crores* for USFDA plant, excluding land cost).

6. Regulatory Support: Dossier preparation (CTD, eCTD), COPP, and query responses

7. Pharmaco-vigilance., Preparation / Reply to GMP, GLP Compliance observation. Get MSME Sustainable ZED Gold Certification.

8. New/Renewal of Mfg. Licenses & Product wise / Country wise - Export Documentations. Get Export Sale's Tax Benefits.

9. Complete Legal Guidance by expert Advocates with supporting documents, For Drugs & Cosmetics Cases throughout INDIA.

10. Visual Aid, Literature Preparation, Ethical Mktg. Product/Sales Training for M.R./ASM, Brand Creation.

11. FSSAI - Label Claim (RDA%), FSSAI Third Party Audit, FSSAI - Central Mfg. License, & FSSAI Product Approval.

12. Assist to buy/sell New or used / Refurbished Lab. Equipment & cGMP Pharma Machines.
    Recruitment of Top Management Staff, Operators, and Technical Staff.
    Guide to buy/sell - factories (cGMP, WHO-GMP, EUGMP, MHRA, USFDA - Plant)