• We have considerable experience in preparing and reviewing regulatory dossier including INDA, ANDA, EDMF, DMF and orphan drug applications
  • We provide end-to-end and cost-effective regulatory services
  • We are a dedicated team and ensure strict confidentiality of all projects
  • We have complete knowledge on the regulations and requirements of region specific Regulatory bodies
  • We are experienced in handling various product developmental issues like pre-clinical pharmacology, manufacturing, clinical studies, toxicology, QC,QA, stability studies, Analysis and validation
  • WE have in-house experts to advise on a wide range of product-related issues for ICH and ROW markets
  • We are an outstanding team of regulatory professionals, biostatisticians, medical writers, pharmacologists and professionals from the core pharmaceutical industry
  • We have a qualified team to check and perform cGMP audits and gather documents for regulatory submissions
  • Our writing and reviewing team compiles, writes and reviews documents as per the CTD format
  • Our expert advisory and solution team handles the post- submission and post-approval queries
  • Our team has a very good reputation and interpersonal relationship with global regulators
  • We prepare an effective strategy before we proceed to file your product
  • We analyze and understand the lacunae at a very early stage of documentation
  • We quickly respond to the post-submission queries from regulators
  • We adhere to all timelines in the product registration process
  • We provide strategic, practical, and real-time solutions to compliance-related queries
  • We monitor your registration process at a micro level, which results in zero-error submissions.
  • Pharmaceuticals (all formulations and APIs)
  • Food and beverages
  • Medical devices
  • Biosimilars and biologicals
  • Diagnostic kits
  • Blood products
  • Vaccines and sera
  • Documentation Support for audits like NABL, ISO, DSIR, DCA, CDSCO
  • Preparation and review of SOPs, STPs and MSPs
  • Consultation services for approvals for pharmaceutical companies and testing laboratories

We recruit highly experienced, educated and talented professionals form pharmaceutical, food and allied life science industries. We also employ qualified scientists and biostatisticians to counter product-related queries.

We have a well-equipped headquarters in Bhubaneswar(India), with 3,500sqft available for our regulatory affairs team. We house state-of-the-art computer systems and dedicated and secure servers. The infrastructure also includes an archival area, video conference room, and meeting room. Our other offices are in Kolkata (India) and Kyoto (Japan).

  • Raw Material Specifications
  • Finished Product Specifications
  • Packaging Material Specifications
  • Process Validation Records
  • Manufacturing Batch Records
  • In process Test Specifications
  • Stability Protocols and Results
  • Reference Standard Details
  • Method Validation Details
  • Development History
  • COA
  • Spectral data on API
  • Dissolution and BE data
  • Site Master File
  • Quality Manual
  • It provides you legal authorization for marketing your products
  • It gives you an edge over your competitors
  • It adds goodwill and reputation to your company and your products covered by DMF
  • It builds the confidence of your customers. Even any unknown customer readily accepts your products
  • It improve sales, broadens your market and cuts down marketing expenses
  • It removes regulatory/legal barriers to enter into advanced marketplaces
  • It creates confidence in your workforce
  • It tones up your knowledge and ensures higher quality for your products. It saves efforts on reprocessing, reworking and rejection-handling.

    Drug Master File (DMF) is a document submitted to the Food and Drugs Administration (FDA), which may be used to provide confidential information about the facility, process or components used in manufacturing, processing, packing and storage of one or more drugs intended for human use. S2M Life Science provides writing, reviewing, registration and renewal of all types of DMF (Type-I to Type-IV)

SL.No Country Regulatory Authority
1 India Central Drugs Standard Control Organization (CDSCO) headed by Drugs control General of India
2 USA United states Food and Drugs Administration (USFDA)
3 UK Medicines and Healthcare products Regulatory Agency (MHRA)
4 Japan Pharmaceutical and Medical Devices Agency (PMDA)
5 Australia Therapeutic Goods Administration (TGA)
6 European Union European Medicines Agency (EMA) European Directorate for the Quality of Medicines (EDQM)
7 Canada Health Canada (HC)
8 France Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS) French Agency for the Safety of Health Products
9 Germany Bundesinstitut für Arzneimittel und Medizinprodukte, (BfArM) Federal Institute for Drugs and Medical Devices
10 Brazil Agência Nacional de Vigilância Sanitária (ANVISA)- The National Health Surveillance Agency
11 Switzerland Swiss Agency for Therapeutic Products (SWISSMEDIC)
12 Singapore Health Sciences Authority (HSA)
13 New Zealand New Zealand Medicines and Medical Devices Safety Authority (MEDSAFE)
14 China SFDA, China
15 Thailand FDA Thailand
17 Nepal Department of Drug Administration, Nepal
18 Israel Ministry of Health,
19 Kazakhstan Ministry of Health
20 Saudi Arabia SFDA,
21 Romania NMA,
22 Morocco Ministry of health,
23 Tanzania TFDA,
24 Zimbabwe MCAZ,
25 Uganda NDA,
26 Algeria ANDS, Algeria
27 Brazil ANVISA,
28 Guatemala MSPAS,
30 Trinidad and Tobago Ministry of Health
31 Paraguay MSPBS,
32 Jamaica Ministry of Health, Jamaica
33 Cuba CECMED, Cuba
35 Columbia INVIMA,
36 Bahamas PHABAHAMAS,
37 Mexico COFEPRIS,
38 Kenya Pharmacy and Poisons Board,
39 Namibia NMRC,
40 Jordan JFDA,
41 Malaysia Pharmaceutical Services, Ministry of Health,
42 Korea KFDA,
43 Ghana FDB,
44 Ethiopia DACA,
45 Chile ISPCH,
46 Argentina ANMAT,
47 Nepal Department of Drug Administration (DDA)
48 Bhutan Drug Regulatory Authority (DRA)
49 Sri Lanka National Medicines Regulatory Authority (NMRA)

For more information on service offerings