Regulatory  Affairs

FDA  Submissions

Review, Preparation and Submission of ANDA’s, NDA’s, IND’s, ADE reports and DMF’s 

Review of Drug product labeling, SOPs and Batch Records

Technical writing(Reports, Protocols, Specifications, Policies and procedures)

Audits

Documentation and Facility Audits, Recommendations and help implement corrective actions

Trainings

Presentations of regulatory submission requirements as per FDA and ICH guidelines and recommendations

Technical assistance

Regulatory filings, Suitability Petitions, Contacting regulatory agencies on behalf of clients

.

Technology & Product Development

 Generic Product Development

Formulation and Process development of Solid, Semi-solid and Liquid Dosage forms

Technology Transfer

Technical transfer from Lab, Pilot scale batches to Commercial scale batches

Process optimization program

Validation

Preparation of validation protocols, Procedures