• 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).

• 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)