Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs (RA) plays an important
role in the development, registration, manufacturing and ongoing marketing of pharmaceutical and
biopharmaceutical products. RA professionals help ensure that pharmaceutical products which are to be
registered and/or are already in market, are consistently safe, effective and are of high quality for
consumers. Due to its strategic nature and its purpose to efficiently achieve regulatory approvals, RA
(CMC) collaborates closely with multiple scientific, technical, quality and commercial areas within a
company and/or with external contract manufacturing organizations.
RA (CMC) personnel in Athreva understand the importance and significance of regulatory
knowledge, guidance, industry practices and trends; and have the expertise and experience to interpret
and utilize the same for global pharmaceutical companies. With our experience in pharmaceutical
industry, our goal is to provide knowledge, guidance and advice to help most effectively and
efficiently achieve highest probability of success in obtaining regulatory approval of any
Athreva can support Pharmaceutical, Biopharmaceutical and OTC companies from across the globe for
their regulatory affairs requirements for major global countries. Some of the countries for which
Athreva has robust expertise are - USA, UK, European Union (EU), India, Canada, Australia, S. Korea,
Malaysia, Singapore, Brazil, Argentina, Mexico, UAE, Saudi Arabia
It is not only important, but also imperative for any pharmaceutical and/or biopharmaceutical company
to ensure that their regulatory dossier is complete and proper to ensure smooth regulatory
registration. Incomplete and/or inconsistent dossier affects a company’s product filing process which
impacts their marketing and revenue in the long term.
Athreva’s experienced RA team can assist in developing a robust and compliant regulatory dossier for
globally located Pharmaceutical and Biopharmaceutical companies, including providing information for
documentation requirement for country-based regulations.
To ensure successful regulatory approval of a product, Athreva understands that an adaptive and
flexible regulatory strategy is required that continuously outlines on a progressive note the
regulatory requirements from the initial clinical trial phase, throughout the pre-registration,
registration, post-approval and life cycle management. It is important for any company to strategize
and decide on the most suitable and required registration pathway for their products in any country.
Market authorization and regulatory filing for products like New Chemical Entity (NCE), New Biological
Entity (NBE)/Biological, Generics, Biosimilars, Vaccines and Over-The-Counter (OTC) is stringently
regulated by majority of the countries across the world. Country-based Health Authorities have the
responsibility to ensure that drug registrations in their countries are compliant with all the
necessary regulations for marketing of safer drug products.
Athreva understands the importance of filing and maintenance of regulatory submissions for Active
Pharmaceutical Ingredient (API)/excipients to various health authorities.
Athreva team along with its global partners have the required infrastructure, expertise and experience
for regulatory filing of pharmaceutical and biopharmaceutical products as per country-based health
authority mandated regulations. It is essential for companies to ensure that their submitted dossiers
are error-free and complete so as to receive market authorization on timely note.
It is important for any company to ensure their marketed product continues to be compliant with the
regulations of any country. In pursuit of ensuring safe products for consumers, it is essential for
manufacturers and marketers to periodically update the product dossiers and also renew licenses on
time with health authorities.
Athreva team has the experience to see to it that companies can ensure their existing marketed
products remain compliant with country-based regulations and changing mandates.
It is mandatory in most countries across the world to ensure companies appoint a local
representative/agent or legal representative when the latter’s product is registered in the market.
The purpose of a local agent is to be the face of a company’s product in a country and be their
representative in communicating with the health authority.
Athreva understands the importance of a local representative play in any country pertaining to
registration and lifecycle of a product and that timely notification and/or communication to health
authority is crucial in nature. Athreva has strategic partnership with experienced regulatory
personnel across the globe to ensure companies receive a holistic solution from us when they enter new
markets as part of their business expansion plans.
Do reach us and experience Athreva advantage