Deren Pharma provides full-fledged Regulatory Affairs services to the Pharmaceutical and Lifesciences Companies for their hassle free entry into USA, EU and Emerging Markets. We provide Regulatory Intelligence, guidance at all stages of product development, assistance in dossier compilation & filings, follow-up with Regulatory Authorities for approvals, response to queries (dossier related and GMP related, 483s and Warning Letters) and all support for product Life-cycle Management.
Our team of experts audit your facilities, do the gap analysis, suggest necessary remedial measures to ensure compliances with the regulatory requirements and be inspection ready.
We do regulatory due diligence for our clients during license acquisition, license divestment, company acquisition and selecting new suppliers.
Knowing the gaps, through Gap Analysis is the first step on a company’s path towards regulatory compliance. Once identified, organized efforts Read More
The regulatory framework for pharmaceutical companies worldwide is growing more complex with each passing day and at the same time there is Read More
Deren Pharma regulatory affairs team provides our customers with full support for regulatory product development, regulatory submissions, Read More
Achieve and maintain stringent cGMP standards in a manufacturing facility, as per Global regulatory authorities viz. USFDA, EU-Agencies, Health Read More
Deren Pharma assist to find a suitable, proficient Pharmacovigilance partner for their operation into US and EU. Read More
Deren Pharma assist our client’s requirement for a proficient CRO for BA/BE studies for submissions across the world. Our services includes, Read More
In today’s fast changing environment of the pharmaceutical industry, the due diligence process is of equally high financial importance for seller . Read More