Vikas Kiran's Contact Details

Vikas Kiran's Company Details

Pleiades Therapeutics Private Limited

Hyderabad, Telangana, India • 11 Employees
Pharmaceuticals

As a brief introduction, Pleiades Therapeutics is started with a goal of becoming a leader in "Patient Centric Innovations" to provide end users Pharmacoeconomic benefit. To provide solutions to Unmet Medical Needs (UMN). Our company is newly established by enthusiastic, young technocrats with rich experience in Research and Development of complex generics (small molecules and oral peptides) of various dosage forms and focused on speed and quality. Our team has extensive experience in filing dossier for US, EU, Canada, and Australia, amongst other markets.We have an 8000 sq. ft facility with the state-of-art formulation and analytical facilities to provide service to pharmaceutical industries engaged in drug product development for the global market. Our formulation and analytical suits have ability to handle segments like oncology, potent molecules and general molecules. Our development house will provide a complete one-stop solution for product development as well as customized services as per the customer need.Formulation Services Includes Formulation development and optimization studies at pilot scale Oral drug delivery systems (Solid orals, Liquids and suspensions…etc.) Topical dosage forms: Ointments, creams, gels and lotions etc. Injectables (Liquids/suspensions) RLD characterization studies – Q1/Q2/Q3 Preformulation studies includes Intrinsic solubility, drug-excipient interaction studies, excipient screen studies etc. Pre-clinical batches for PK studies like In-Vivo DMPK studies (small animal studies) Pilot/bio-batch manufacture (Clinical testing) Submission batch manufacturing supportAnalytical Services Include: Active pharmaceutical ingredient testing Method development, refinement, technology transfer & validation Cleaning method validation Stability studies and testing as per ICH guidance Regulatory and technical management Regulatory assistance and monitoring Submission assembly and preparation FDA response preparatio