Regulatory Affairs

Regulatory affairs professionals

Regulatory affairs are another core area for clinical trials. Pharmaceutical firms need a constant update on in-and-out on country-specific regulatory and ethics requirements to keep compliant with ever-changing legislation.
A team regulatory affair at Pepgra CRO advice on legal and scientific restraints from a global perspective thereby help you achieve your goals

Pepgra CRO offers its clients high quality Clinical and Regulatory Expert Services. Our expertise in the regulatory services draws extensively on the latest research for helping you design and implement clinical, regulatory framework depending on their requirement. Our services in regulatory services have been widely appreciated by our clients from pharmaceutical and biotechnology industries.

Our experts in regulatory affairs from world’s top pharmaceutical firms pay the closest attention to providing support in developing new medicinal products, integrating regulatory principles, and drafting and submitting relevant reports to health authorities. Our project management team will gather all documents including informed consent forms, writing the information for volunteers, competing the online IRAS form and also obtain necessary documentation and specialist opinion for ethics submission. We guide our clients in planning and implementing post-marketing activities. We provide enhanced guidance to the start-ups in discovering, testing, manufacturing, and marketing of medicinal products and thus ensure that the products supplied to make a useful contribution to public health.

We offer our clients customized service assistance in decision making, planning and management, and availing and executing strategic training and projects. Our experts keep a close track of the periodic and interim changes in the legislation in various regions and guide our clients in incorporating necessary changes in the products and advise them on legal and scientific restrictions and requirements. We deem it as our responsibility to employ the expertise of our legal advisors to negotiate with health authorities to obtain marketing authorization for medicinal products. Pepgra CRO understands the value of offering their clients access to international biopharmaceutical industry experts. One of the primary objectives of Pepgra CRO is to enable their clients to achieve their enterprise goals through increased product value and cost-effectiveness. We value the time our clients invest with us and the trust they have in our services. Therefore, we always push ourselves to deliver the best to them in all our services

Comprehensive Regulatory affairs Solutions

    We serve you in
    • abbreviated new drug application (ANDA)
    • investigational medicinal dossier (IMPD)
    • CTA submissions
    • paediatric investigation plan
    • reformatting of dossiers
    • financial analysis and agreement terms for licensing and acquisition
    • health technology assessment
    • medical and regulatory writing
    • clinical development
    • commercial assessment and valuation of biopharmaceutical assets
    • health technology assessment
    • pricing and market access
    • product and portfolio decision making
    • statistics and data analytics
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Pepgra has the information you need to be abreast with the ever changing medical and pharmaceutical regulatory affairs, also known as RA in short. Our RA professionals work with FDA and EMA means that you proactively get to know the regulatory climate.

 
 

We deliver study designs balanced to meet your business needs and expectations with the current scientific understanding and all regulatory requirements considered.

Allow us to help propel your product forward.

 
RA professionals know the market like the back of their hand. Considering the fact that it takes 15 years to put your drug on the shelf; you want to bet your stakes on a partner, who can guide your thru the maze of regulatory changes. Pepgra is that partner.

— John Mace, Senior Director of a leading drug manufacturer.

The agility to

grow with your needs

Our process, technology solutions and culture of excellence give us the ability to scale up
without compromising on quality

 
 

Have a business query? Let’s talk.

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