US/EU DMF Compilation•EXCIPIENT/ Packing Material DMF Compilation•Dossier Compilation•ACTD/CTD/Regional Dossier•Dossier for Herbal and Nutraceutical Products•Variance Filling. Specialization : Analytical Method Development and Validation, Formulation Development and ValidationRegtechIndia Solutions has started since 2013 under the name of Regulatory Affairs. We are a young consultancy with professionals that have been working in the pharmaceutical industry for more than 10 years. Our company is specialized in providing National and International Regulatory consulting services in Health Products. we are differ from the rest due to our big knowledge of the regulatory framework of Drug, Cosmetic and Medical Devices within Asian Countries and Latin American countries.Our main objective is that our clients feel that we are part of their companies; we show an honest regulatory outlook and provide real solutions prioritizing the needs of every client and showing the commitment we assume on creating every new labor alliance.Absolute confidentiality, transparency, and professionalism define us when facing a project.To contact us: info.regtechindia@gmail.com : shrutikharidia@gmail.comwebsite: regtechindia.net

• Work for the countries like South East Asian countries (Philippines, Myanmar, Thailand, Vietnam, Colombia, Srilanka, etc), Latin American countries (Chile, Venezuela, Peru, Bolivia, Uruguay, Costa Rica, Georgia, El Salvador), African Countries (Ghana, Nigeria, Cameroon, Burkina Faso, Mauritania, Uganda, Algeria, Kenya, etc.)• Prepare and review ACTD and CTD dossiers.• Query/Compliance document preparation and reviewing of documents.• Preparation and reviewing of artwork and insert.• Communication with Clients regarding Registration Requirements.• Managing the team of 20 persons• Work for Govt. tenders of different countries like Burkina Faso, Algeria, Niger, Gabon, Cameroon, United Nations, Vietnam, etc.• New product development like sterile solution for injection and powder for injection dosage forms.• Sourcing of API for new product development.• Communication with clients regarding contract manufacturing of products.

Formulation Development for US/EU and Canada Market.Dosage Forms : Pellets in Capsule, Tablets and Capsules

Formulation Development for ROW market for Tablet, Capsule, Syurp and Cream Dosage form.