Preparation of Safety Data Sheet (SDS) for chemical, API and finished product-

Safety Data Sheets (SDSs) are a critical component, required by law for safe manufacturing operations as they contain basic information about a chemical or product which helps to ensure the safety and health of the user at all stages of its manufacture, storage, use, and disposal.

Preparation of Non-clinical Overview and Non-Clinical Summary of pharmaceutical product-

Non clinical overview is an integrated and critical assessment of the pharmacological, PK and Toxi evaluation of a pharmaceutical Required for Registration of drug products, regulatory dossier submission in the form of CTDs (an integral part of CTD), part of IND or NDA filing or (505 (b2) applications.

Prescribing Information-Pregnancy Lactation and labeling Rule (PLLR)

labeling -Effective date June 30, 2015.

Prescription drug labeling sections 8.1, 8.2 and 8.3

Section 8.1 - Pregnancy including labor and delivery

Section 8.2 - Lactation including nursing mothers

New Section 8.3- Female and male of reproductive potential.

• Compilation of dossier (CTD) format based on the documents and inputs provided by the clients. Response to regulatory queries is subjected to support provided by the clients.